MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 NEUT 32IDX48OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121932448
Medical Device Problem Codes	Disassembly (1168); Noise, Audible (3273)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It states that the pinnacle hip acetabular component revised due to poly liner disassociation.Also, operated hip worked fine until (b)(6) 2017, when unexpectedly it began to squeak loudly as a dry door hinge.The voice was clearly audible to outsiders too.The next day, the hip started to bother and locked up so that the knee could not be raised to 90 degrees.Orthopedic surgeon told during the surgery that the artificial hip was implanted correctly.He could not even say why it was broken.Overweight should not be a cause for break because my sister has the same artificial joints in both hips and is considerably more overweight than me.She has had no problems and they have been several years, another six years and the other four.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device finds evidence to support an in-vivo disassociation event.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MAR +4 NEUT 32IDX48OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6968585
• Report Number: 1818910-2017-27256
• Device Sequence Number: 1472482
• Product Code: LPH
• UDI-Device Identifier: 10603295014317
• UDI-Public: 10603295014317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 121932448
• Device Lot Number: 685234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 10/20/2017; 02/26/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 11/08/2017; 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 102