MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX LIP LNR 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122132254
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	05/15/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
Ppf alleges fracture (bone) and infection after first revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: ALTRX LIP LNR 32IDX54OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8276903
• Report Number: 1818910-2019-82227
• Device Sequence Number: 11352097
• Product Code: LPH
• UDI-Device Identifier: 10603295016205
• UDI-Public: 10603295016205
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: 122132254
• Device Lot Number: FF1FA1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/07/2019
• 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
• Patient Age: 69 YR