MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 28IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-28-048
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	11/22/2019
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
Sales rep reported: "i received a complaint about a hip implant that broke".Code and lot numbers were not informed.Just the opco: depuy joint.
Additional Manufacturer Narrative
Product complaint # (b)(4).
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: examination of the acetabular liner confirms the reported observation.The investigation has not however identified product error.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: 120553.No related deviations or anomalies were identified.Device history batch: null device history review: lot: 120553.No related deviations or anomalies were identified.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 28IDX48OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9506032
• Report Number: 1818910-2019-124487
• Device Sequence Number: 2981756
• Product Code: KWA
• UDI-Device Identifier: 10603295013280
• UDI-Public: 10603295013280
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2019

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: 1219-28-048
• Device Catalogue Number: 121928048
• Device Lot Number: 120553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 02/25/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/22/2020; 02/26/2020
• 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