MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR LIP LNR 32IDX52OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121932252
Medical Device Problem Codes	Disassembly (1168); Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/25/2017
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
Der states that the patient had right primary hip on (b)(6) 2015.At that time a 52mm pinnacle sector ii cup was implanted with x2 30mm screws, a marathon 32x52 lipped liner, +1 32 delta head and sz 5 summit std stem.On (b)(6) 2017 patient returned to or.Following 6 months of pain in same hip.Patient suffered no dislocation.Hip opened and liner found to be disassociated from the shell.Liner removed,x2 screws removed and new liner (altrx +4/10 32id) + delta ball implanted.
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
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.
Additional Manufacturer Narrative
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 MAR LIP LNR 32IDX52OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6885934
• Report Number: 1818910-2017-25174
• Device Sequence Number: 659838
• Product Code: LPH
• UDI-Device Identifier: 10603295014188
• UDI-Public: 10603295014188
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/25/2017

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: 121932252
• Device Lot Number: 674042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 10/23/2017; 10/24/2017; 10/24/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/24/2017; 10/25/2017; 10/25/2017
• 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: 65 YR
• Patient Weight: 123