MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 10D 40IDX64OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS

Model Number	1218-40-764
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Discomfort (2330); Joint Disorder (2373); Test Result (2695); No Code Available (3191)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient has a history of surgeries on his hip.I do not have previous operative reports, labs, or clinical correspondence to share.The history that is documented was stated to me by the surgeon.This patient had his er hip replaced in 2009 with a smith and nephew birmingham metal on metal hip replacement.This patient was revised in 2012 by the surgeon where the birmingham hip was explanted and a summit stem with a pinnacle cup.The patient began to have dislocation issues after that revision and seen the surgeon in 2013 where he received a 40mm hip ball and constrained liner for the pinnacle cup.This patient came and seen the surgeon in 2018 with discomfort in his hip.The surgeon has done labs over the last few years to monitor his co and cr levels.Over time the patients co cr levels elevated.The surgeon decided to revise the hip, he found the stem was impinging on the 10degree lip constrained liner and created metal debris in the hip.A new hip ball and a neutral constrained liner was implanted.The summit stem and pinnacle cup were left in situ.Doi: (b)(6) 2013; dor: (b)(6) 2020; right hip.
Additional Manufacturer Narrative
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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN LNR CON +4 10D 40IDX64OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9640227
• Report Number: 1818910-2020-03198
• Device Sequence Number: 379762
• Product Code: KWA
• UDI-Device Identifier: 10603295012238
• UDI-Public: 10603295012238
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1218-40-764
• Device Catalogue Number: 121840764
• Device Lot Number: 187949
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91