MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1219-36-056

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Fever (1858); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Tissue Damage (2104); Fluid Discharge (2686); No Code Available (3191)

Event Date 07/09/2009

Event Type  Injury  

Manufacturer Narrative

(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

Legal claim received with medical records attached.Medical records state: gross periprosthetic right hip infection.Litigation received 6-sep-2012 alleged infection.Update ad 8 june 2018: in addition to what was previously reported, ppf alleges pseudotumor, infection and elevated metal ions after the first revision.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records, it was reported that the on (b)(6) 2009 debridement with liner and head exchange at newton wellesley hospital.Cultures reveal poly bacterial infection mainly with propionibacterium acnes as well as mrsa and mssa as well as a 3rd type staphylococcus.Patient had fever episodes 2 days later after discharge on (b)(6) 2009.Despite extensive treatment the patient did show clinical deterioration with pronouns drainage of the right hip incision clearly with pus contents, fever episodes and increase inflammatory markers.The patient was then revised for polybacterial periprosthetic right hip infection.Operative notes reported that there were 2 draining opening in the mid and distal part of the incision.There was gross infection in all the tissue plains, including subcutaneous, fascia lata and abductor muscle and the actual joint space.The femoral neck and the acetabulum showed impingement traces in extension with significant metal substances loss well explaining the previously noted metallosis.An attempt was made to disconnect the sleeve from the main stem component using j j wedge osteotome, despite enormous effort, this was not accomplished.Then necrotic tissue around the acetabulum was removed.Surgical findings also reported gross periprosthetic right hip infection with pus content in all layers.Pseudotumor tissue mainly posteriorly along the component well-fixed both on the femoral and acetabular side.Impingement signs at the femoral neck posterolateral and corresponding along the acetabulum posteriorly, consistent with component impingement in extension.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Replaced surgical intervention with device revision or replacement.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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 #: pc-(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: b5 and h6 (clinical code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Non mom medical records received: page 101-118: revision op notes.On (b)(6) 2009 the patient had a right revision to address cellulitis and infection.Cultures on (b)(6) 2009 noted infection was quite deep.The liner and head were revised.Page 118 of the 978 sticker sheet shows the patient had an srom metal on-metal femoral head implanted along with a pinnacle marathon acetabular liner (poly) implanted.(pc-(b)(4)).Page 369 - 371 clinical notes and lab results medical records note that on (b)(6) 2009 the patient underwent an it band release (due to pain), which revealed anterior avulsion of abductor muscle, as well as metallosis and no growth from cultures taken.On (b)(4) he had i and d which revealed several layers of pus and significant metallosis.Cultures were positive for mrsa.Specimen from (b)(6) 2022 shows focal coagulative necrosis.*right total hip was implanted 2007, the release of it band (b)(6) 2009, washout and hardware removal (b)(6) 2009, and planning to remove all hardware (b)(6) 2009 (pc-(b)(4)) page 425 -427 radiology report radiograph report from (b)(6) 2009 reporting finding of metallic wiring transfixing the comminuted proximal femoral shaft fracture.Page 721 - 722: revision note.On (b)(6) 2009 the patient had a right hip irrigation and debridement with extended trochanteric osteotomy for tha removal.

• Brand Name: PINN MAR NEUT 36IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8200187
• MDR Text Key: 131524796
• Report Number: 1818910-2018-79228
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295014461
• UDI-Public: 10603295014461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/06/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2012
• Device Model Number: 1219-36-056
• Device Catalogue Number: 121936056
• Device Lot Number: BN4AL1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PINN CAN BONE SCREW 6.5MMX20MM; PINN MAR NEUT 36IDX56OD; PINNACLE BONE SCREW 25 MM; PINNACLE SECTOR II CUP 56MM; S-ROM M HEAD 36MM +0; S-ROM*SLEEVE PRX ZTT, 18B-LRG; SROM STM STD 36+12L 13X18
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male