MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR NEUT 32IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932058
Medical Device Problem Codes	Disassembly (1168); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
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
Complaint description: depuy17-30.  it was occured a dislocation of the pinnacle marathon pe neutral liner 32idx58od that was implanted in 2011.The event was not linked to any trauma.It was necessary a new intervention.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: updated february 27, 2019.The device was returned for examination.Examination of the returned acetabular liner finds sufficient evidence to confirm the reported disassociation event.The investigation has not identified product error.The manufacturing records have been reviewed and no related deviations or anomalies were identified.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.Device history lot: null.Device history batch: null.Device history review: null.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 NEUT 32IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7333620
• Report Number: 1818910-2018-54931
• Device Sequence Number: 416472
• Product Code: LPH
• UDI-Device Identifier: 10603295013938
• UDI-Public: 10603295013938
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2017

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: 121932058
• Device Lot Number: E15RY1000
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 03/13/2018; 05/25/2018; 05/10/2019
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 03/13/2018; 05/31/2018; 05/10/2019
• 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