MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 28IDX50OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121928150
Medical Device Problem Codes	Disassembly (1168); Material Separation (1562); Noise, Audible (3273)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Joint Disorder (2373); No Information (3190)
Date of Event	12/07/2015
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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
The patient was revised to address disassociation of hip-head and inlay.
Additional Manufacturer Narrative
(b)(4).Following review by bioengineering, no product problem was identified.The complaint shall be closed with an undetermined conclusion.It shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be re-opened and further investigation completed as required.Device history review: reviewed the dhr (attached (b)(4)).The parts were processed per the requirements and completed the required sterilization cycle.No parts were scrapped or reworked.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
Complaint description: the patient was revised to address disassociation of hip-head and inlay.

• Brand Name: PINN MAR +4 10D 28IDX50OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7142711
• Report Number: 1818910-2017-29761
• Device Sequence Number: 19064162
• Product Code: LPH
• UDI-Device Identifier: 10603295013464
• UDI-Public: 10603295013464
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121928150
• Device Lot Number: 653556
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 03/09/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 01/03/2018; 03/12/2018
• 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: 43 YR
• Patient Weight: 74