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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX +4 10D 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX +4 10D 36IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1221-36-154
Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Patient Problems Adhesion(s) (1695); Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671); No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)
Event Date 02/16/2018
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
Der states that one week ago (which was approx 2 years post-op) the patient was standing on a desk and felt a "pop" in her hip followed by discomfort.She went back to the surgeon and x-ray revealed some sort of failure at the liner shell interface.Revision surgery revealed that the poly had dissociated from the shell.There was no damage to the shell and it was retained.The head and poly were exchanged.Doi: (b)(6) 2016; dor: (b)(6) 2018; left hip.
 
Manufacturer Narrative
Product complaint # : (b)(4).Visual examination of the returned device finds nothing outward to suggest product error.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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
Litigation records pertaining to the pinnacle altrx polyethylene acetabular liner were received alleging injury, pain and audible squeaking while walking.Radiographs were taken and it was noted that the femoral head was no longer centered within the acetabular cavity.During surgery, it was confirmed that the liner had disassociated.Records further allege discomfort, limitation of movement, diminished ability to function in daily life, disfigurement, anxiety, frustration, worry, concern and general emotional upset.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.Udi: (b)(4).No code available use for device revision or replacement.
 
Event Description
Pfs and medical records received.Pfs alleges weakness and instability.After review of medical records patient was revised to addressed failed left total hip arthroplasty with polyethylene liner disassociation.Operative notes indicated minimal black staining from the wear of ceramic head, pseudocapsule and scar was excised, some chronic and long term deformation of acetabular component.Doi: (b)(6) 2016 dor: (b)(6) 2018 left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.H10 additional narrative:.
 
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.Device history lot :699829.H10 additional narrative: added: h6.Corrected: d7.
 
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.Device history lot
=
> 699829.H10 additional narrative: .
 
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.Device history lot: 699829.
 
Event Description
Medical records were received and stated the following: on (b)(6) 2011, a bone densitometry examination was performed.On (b)(6) 2015, patient received 1st of physical therapy initial examination.
 
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.
 
Event Description
On (b)(6) 2016, the patient had a primary left hip arthroplasty (there is a discrepancy on the actual implant date, but it is consistently in 2016).On (b)(6) 2018, the patient underwent revision due to disassociation of the liner from the cup with no immediate explanation for why the acetabular liner had dissociated.The locking mechanism of the acetabular shell was intact and the surgeon elected to not revise the cup.Patient reports having joint pain prior to surgery.
 
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 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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Medical records received.On (b)(6) 2016, the patient had a primary left hip arthroplasty along with repair of gluteus minimus tendon tear, to address left hip arthritis secondary to developmental hip dysplasia.Depuy components were implanted during this procedure.
 
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: b5.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: according to the information received, ¿der states that one week ago (which was approx 2 years post-op) the patient was standing on a desk and felt a "pop" in her hip followed by discomfort.She went back to the surgeon and x-ray revealed some sort of failure at the liner shell interface.Revision surgery revealed that the poly had dissociated from the shell.There was no damage to the shell and it was retained.The head and poly were exchanged.Doi: on (b)(6) 2016; dor: on (b)(6) 2018; left hip.¿ the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the returned device and review of the x-ray evidence finds evidence to support disassociation of the liner and acetabular cup.Some anti-rotation device (ard) tabs of the altrx +4 10d 36idx54od were found sheared off.On the inner rim surface, there is some evidence of subluxation and therefore edge loading by the femoral head.The area of damage being described is opposite the 10 degree feature of the liner.In this area three of the ards are yet intact.However, there is not enough evidence to determine if audible sound could be caused by the liner and another device.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device [122136154 / 699829] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the altrx +4 10d 36idx54od would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device [122136154 / 699829] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device [122136154 / 699829] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.
 
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Brand Name
ALTRX +4 10D 36IDX54OD
Type of Device
PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key7331192
MDR Text Key102114823
Report Number1818910-2018-54880
Device Sequence Number1
Product Code LPH
UDI-Device Identifier10603295016410
UDI-Public10603295016410
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072963
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Model Number1221-36-154
Device Catalogue Number122136154
Device Lot Number699829
Was Device Available for Evaluation? No
Date Returned to Manufacturer03/01/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2015
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
ALTRX +4 10D 36IDX54OD.; CORAIL2 LAT COXA VARA SIZE 12.; CORAIL2 LAT COXA VARA SIZE 12.; DLT TS CER HD 12/14 36MM +5.0.; DLT TS CER HD 12/14 36MM +5.0.; PINN CAN BONE SCREW 6.5MMX45MM.; PINN CAN BONE SCREW 6.5MMX45MM.; PINN SECTOR W/GRIPTION 54MM.; PINN SECTOR W/GRIPTION 54MM.
Patient Outcome(s) Required Intervention;
Patient Age60 YR
Patient SexFemale
Patient Weight86 KG
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