MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX +4 10D 36IDX64OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122136164
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
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
Pfs and medical records received.There is no allegations.After review of medical records for the mdr reportability, it was reported that the liner was not seating correctly and was damaged when removed from hip.Doe: (b)(6) 2017.This pc is linked to (b)(4).
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Device history review it was noted during the manufacturing process that this order was put on hold at the "unload - gas plasma" phase for the sterilizer aborting mid-cycle, and were reworked through standard rework operations by re-sterilizing the order.However.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALTRX +4 10D 36IDX64OD
• 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: 7295624
• Report Number: 1818910-2018-54032
• Device Sequence Number: 13823891
• Product Code: LPH
• UDI-Device Identifier: 10603295016465
• UDI-Public: 10603295016465
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 122136164
• Device Lot Number: C77710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 109