• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 48OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 48OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS Back to Search Results
Catalog Number 121882748
Device Problem Fracture (1260)
Patient Problems Pain (1994); Scar Tissue (2060); Discomfort (2330)
Event Date 01/24/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Surgeon reported to bfarm: "implantation of a hip-tep left side on (b)(6) 2021.Discomfort in the course.Revision surgery on (b)(6) 2022; during this replacement of a fractured ceramic inlay." doi: (b)(6) 2021; dor: (b)(6) 2022 left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Surgeon reported to bfarm: "implantation of a hip-tep left side on (b)(6) 2021.Discomfort in the course.Revision surgery on (b)(6) 2022; during this replacement of a fractured ceramic inlay." doi: (b)(6) 2021; dor: (b)(6) 2022 left hip.
 
Event Description
Medical reports reviewed and stated the following: are the explantat/explantate available for examination? antowrt: yes, but not completely, not all fragments of the broken ceramic inlay are present.Ref and lot of all components used in (first) implantation.Op 2.8.21 first implantation.Depuy orthopedics gmbh 121701048 9794703 pinnacle¿press fit pan 100, outside diameter 48 mm, without holes, porocoat® coating.Depuy orthopedics gmbh 124603000 d20080124 pinnacle¿/duraloc¿option¿ apex hole closure.Depuy orthopedics gmbh 121882748 9738110 pinnacle¿spirofit¿ceramaxinlay, ceramic, internal diameter 32 mm, outer diameter 48 mm.Depuy orthopedics gmbh 3l92510 5382473 corail¿amt hip, size 10, length 140 mm, hydroxyapatite coating , standard/ks, without collar depuy orthopedics gmbh 136532310 9673859 ceramax¿biolox® delta ceramic hip head, cone 12/14, diameter 32 mm, neck length +1 mm (short) removal of ceramic inlay and prosthetic head on 24.1.22 replacement on 24.1.22 by: depuy orthopedics gmbh 122132148 jn7538 pinnacle¿spirofit¿inlay, altrx¿, internal diameter 32 mm, outside diameter 48 mm, +4, 10° depuy orthopedics gmbh 136521000 d21102699 metal hip head, cone 12/14, diameter 32 mm, neck length +1 mm did an or time extension occur? answer: no.Were there any adverse consequences for the patient due to the reported event? answer: revision operation.X-rays as an attachment patient information 60 years , 165cm, 65kg, right side, activity level normal.Extracts from clinical correspondence medical history of the first procedure (b)(6): for about two years, the patient has had progressive resting and stress-related pain in the area of the right hip joint.There is a start-up pain after rest periods, the walking distance and the climbing of stairs are clearly restricted, also the mobility.There is swelling on the thigh medial toward the groin.This is constant.So far, physiotherapy has been used, but there has been no lasting improvement.Medical history for the second procedure (b)(6): the patient complained about the pain in the area of the hip joint on the left during admission.She was given a hip joint endoprosthesis in domo about half a year ago.After initially inconspicuous postoperative course, the patient complained of sudden pain and crepitations in the left hip area during the dress in (b)(6) 2021.The indication for the change of inlay (ceramic inlay) was given with the corresponding image result.Information on implant removal reason: broken ceramic inlay.Op_first implantation report joint team-time-out discussion of patients with specific risk factors with colleagues in the anesthesia department.Patient in right-side storage, itn.After disinfection and sterile coverage of the surgical area, the arched skin section is performed over the left trochanter major up to the glutaeal region.Separating subcutis, a large, flammable modified mucosal bag is shown here, which is excited in toto and sent for histological treatment.Cut the fascia lata, suppress the glutaeus maximus according to dorsal and represent the nervous system ischiadicus.Insert the hohmann levers and show the small outer rotors.Set down and attach the piriformis and gemelli musculus while maintaining the quadratus femoris muscle, so that the function can be restored later in the course of soft part balancing.The hip joint capsule is opened from dorsal under subtle blood stillation.Considerable dorsal pannenandosteophytes were shown, these are carefully removed with the chisel and the luer pliers.Now the heavily arthrotically altered hip head can be luxury to dorsal.A massive thickening and inflammation of the joint mucosa in the sense of a pronounced synovialitis with a chronic inflammatory reaction is shown.Perform a synovialectomy with pe withdrawal.Due to the massive inflammatory reaction, extremely time-consuming and subtle blood stasis has to be carried out.The head is strongly deformed, so that the joint relations are distorted and considerably narrowed.Display of the femur head and neck, whereby disturbing blood vessels are also coagulated.Setting down the femur head.The femur head is set down in the area of the thigh neck at a 45° angle.The opening of the thigh neck with the box chisel is now carried out, which is set to far lateral and far dorsal.This leads to increased bleeding along the head-neck vessels, the bleeding is breastfed.The visibility is still difficult.The reamer is guided deep into the marker space for centering, taking care that it is pressed in the direction of the trochanter major to avoid varus mispositioning.Then prepared the shaft bearing with ascending raspels.Pronounced osteophytes are now present in the area of the trochanter major , which must be removed in complex small-step technology in the case of massive sclerosis bone tissue.The distance between the proximal shoulder of the prosthesis and the trochanter major, measured in the pre-operative planning, serves as an orientation for the further procedure.The raspels are introduced and retracted in turn with small precise hammer strokes, whereby from the beginning a concrete anteversion of approx.10° is observed.The definitive collection is carried out with the raspel of size 10 planned in the x-ray image.The rotation-resistant press-fit seat of the last selected rasp is checked again via the rotary rod on the rapeseed handle.Transfer of the leg to prepare the pan.During this process, remaining capsule and cartilage components are to be worn.Representation of the original pan.Removal of the soft parts there.Stronger bleeding, this is electrothermal.The round milling is then used to arrive in ascending order from 44 up to the final pan diameter of 48 mm.The bottom of the pan is significantly cystic/osteolytic , so that we decide to carry out a corticospongious chip implantation (analogue material from the removed hip head) in order to ensure the proper growth of the pan.Now a homogeneous bottom of the pan is apparent.The implant size is determined with the manipulator shell and the installed alignment gauge.Depending on the bone bearing quality, an implant size of the final cup size 48 pinnacle presfit is chosen, whereby care is taken that a subchondral lamella, which has been modified by sclerosis, but is stable, can be obtained in the supporting part of the intestinal bone.When placing the pan with the pan impact instrument, care is taken that the pinnacle pan is brought in in 45° inclination and 10°-15° anteversion.By checking the shell seat at the apex hole with the test hook, the firm press-fit on the acetabutum bottom is documented.Finally, a ceramic inlay of size 32 is inserted with the help of the setz impact instrument in such a way that it is securely jammed.Transfer of leg.The repositioning is carried out with the rasp reinserted, as well as various test containers and test heads, until the desired offset and the desired leg length are reached.Functional test and luxury test.Now a definitive prosthesis with the size 10 is used and until complete stabilization with small hammer strokes is driven in.Now insert the head again size 32/+1 and check the function again.Exchange for the original implants.Flushing of the joint, most careful blood treatment.Now subtle readaptation of the capsule as well as the small outer rotators with careful consideration of the muscle balancing to correct the pre-existing axis mispositioning.Image converter documentation.Now carry out a lia with 200 ml of naropin solution, suture of the muscle fascia, taking into account the tension conditions, insertion of a redon drainage, subcutaneous seam, after renewed skin disinfection, clam seam of the skin, sterile dressing, compression bandage according to speaker.Op report revision: patient in right-side storage.Itn.After disinfection and sterile cover of the operating area, skin cut over the left hip joint under plastic scar cut.Cut the subcutis, enter the depth.Opening of the hip joint via the dorsal access.The operative procedure is considerably more complicated and complicated due to its considerable scarring.Now open the capsule.Swab removal.Further preparation under complete excision of the dorsal hip joint capsule.Finally, the total endoprosthesis is luxated to dorsal.Knock off the ceramic head.A good overview of the joints is produced: like the clinic, fragmented polyethylene inlay in the area of the pan.Now the femur shaft is pushed over the front edge of the pan.Remove the inlay.Penibeles collect all the ceramic splinters.Extensive flushing with jet lavage.Multiple flushing of the wound area.Then press in a dysplasia inlay size 48/32, striking a chromium-cobalt head size 32/+1.Complete synovectomy with release of material for histology and finally repositioning of the joint.Careful wound cleaning.Blood stasis.Inserting a redondrainage.Layered wound closure.Sterile wound dressing.Compression bandage.Procedure: pain-adjusted full load on forearm supports.Remove redondrainage on day 2 postoperative.Removal of the suture material on day 10 postoperative.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was received for analysis.Visual examination of the returned device along with provided xray images, confirmed the reported event.The ceramic insert was fractured into multiple pieces.Also, it was observed a worn appearance at the part.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the ceramic insert belongs to the shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.Device history review : a manufacturing record evaluation was performed for the finished device (121882748/9738110) product and lot numbers, and no non-conformances were identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DELTA CER INSERT 32ID X 48OD
Type of Device
PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI  
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13479403
MDR Text Key285221356
Report Number1818910-2022-02459
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number121882748
Device Lot Number9738110
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 10; DELTA CER HEAD 12/14 32MM +1; DELTA CER INSERT 32ID X 48OD; PINNACLE 100 ACET CUP 48MM
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient SexFemale
Patient Weight65 KG
-
-