MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-456

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Pain (1994); Fibrosis (3167); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Patient reports pain secondary to left hip pseudotumor that is affecting his daily life.Left tha is failing due to pseudotumor confirmed on imaging.Revision recommended. .

Manufacturer Narrative

Product complaint # (b)(4).The initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.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 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.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).Investigation summary: according to the information received, ¿left hip is now failing and on imaging i have a pseudotumour developing which is causing pain and affecting daily life.I have consulted with a number of hip arthroplasty specialists and the advice is to have it revised.Obviously for a young man this is not ideal and certainly not what i would have expected from what i have promoted for years as the rolls royce of total hips.A hip for life¿.The pinnacle metal insert (p/n 121887456, lot# 2928798) associated with this report was returned to depuy synthes and forwarded to material science for evaluation.Visual inspection of the cocrmo acetabular liner showed significant scratching radially, perpendicular to the face/rim of the liner, on approximately 65% of the outer diameter of the articulating surface of the liner as well as a few discontinuous bands of scratching along the inner articulating surface of the liner.Based on the relationship of this damage to the sector holes of the acetabular cup of the left hip, scratching of the liner is within the region of loading for the femoral head within the liner and suggests third body wear.No titanium was detected that would suggest third body wear due to porous coating debris.Device history lot: a search of the depuy synthes quality system was performed for lot number 2928798 and no non-conformances were identified from the review.Furthermore, the product is not involved in a recall.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the photographic and x-ray evidence cannot confirm the reported allegation.Based on the quality of the photo evidence, no signs of deterioration on the inner surface of the liner was observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device found the metal liner assembled on the cup.Slightly marks can be observed on the internal surface of the liner, most likely caused during the extraction process.No signs of metal deterioration were found, there the reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received.A.Has any loosening of the femoral or acetabular components occurred? if yes, which interface is the loosening? -both femoral stem (corail) and acetabular shell (pinnacle) are well fixed.B.Did the primary surgeon utilise cement? if yes, was the cement manufactured by j&j? -both components are uncemented.C.Are there any relevant patient demographics to consider in relation to this adverse event other than the pseudotumour? -no.I am a fit 52 year male with no other comorbidities or reason for pseudotumour development other than the know relationship between cobalt and chromium debris and pseudotumour formation.

• Brand Name: PINNACLE MTL INS NEUT40IDX56OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16688933
• MDR Text Key: 312770983
• Report Number: 1818910-2023-07482
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: 1218-87-456
• Device Catalogue Number: 121887456
• Device Lot Number: 2928798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 05/22/2023; 06/13/2023; 06/21/2023; 07/07/2023; 08/25/2023
• Supplement Dates FDA Received: 05/30/2023; 06/15/2023; 06/22/2023; 07/10/2023; 08/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CORAIL2 STD SIZE 13; DLT TS CER HD 12/14 40MM +1.5; DLT TS CER HD 12/14 40MM +1.5; PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT40IDX56OD; UNK HIP FEMORAL STEM CORAIL; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male