MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX LIP LNR 36IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122136258
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	05/10/2019
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
Revision thr - summit pinnacle original surgery performed (b)(6) 2019.Patient dislocation.Dr revised liner and head.Originally 58 lipped pinnacle liner and 36 +8.5 ceramic head.Revised into 58 +4/10 liner and 40 +12 ceramic ts head.
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.
Event or Problem Description
The affected side was left.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot = > a manufacturing record evaluation was performed for the finished device lot hn9345 and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALTRX LIP LNR 36IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; depuy orthopaedics inc us; warsaw IN 46582 0988
• MDR Report Key: 8654657
• Report Number: 1818910-2019-94821
• Device Sequence Number: 16785828
• Product Code: LPH
• UDI-Device Identifier: 10603295393191
• UDI-Public: 10603295393191
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 05/11/2019

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 Catalogue Number: 122136258
• Device Lot Number: HN9345
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2019
• Supplement Date Received by Manufacturer: 05/30/2019; 08/05/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/05/2019; 08/05/2019
• 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: 44 YR