MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN LINER NEUT 32IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121832060
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377)
Date of Event	09/20/2018
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
Pain, asymmetric pe wear and osteolysis at trochanteric area.
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.
Additional Manufacturer Narrative
(b)(4).Investigation summary: following inspection of the returned products and review of the information received, it was concluded that it was unlikely that a manufacturing defect was present.The complaint shall be closed with an undetermined conclusion, it shall be entered onto the complaints database and monitored through trend analysis.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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: following inspection of the returned products and review of the information received, it was concluded that it was unlikely that a manufacturing defect was present.The complaint shall be closed with an undetermined conclusion, it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN LINER NEUT 32IDX60OD
• 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: 7960164
• Report Number: 1818910-2018-72316
• Device Sequence Number: 1681543
• Product Code: LPH
• UDI-Device Identifier: 10603295011583
• UDI-Public: 10603295011583
• Combination Product (Y/N): N
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/21/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 121832060
• Device Lot Number: ZD4GY1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 09/21/2018; 11/16/2018; 12/19/2018; 12/19/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/28/2018; 11/29/2018; 12/19/2018; 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR