MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR HA ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121712054
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/14/2011
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 of right thr - high metal ions.Pain.Doi: (b)(6) 2008; dor: (b)(6) 2011; right hip.
Additional Manufacturer Narrative
Product complaint # : (b)(4).
Additional Manufacturer Narrative
Product complaint: (b)(4).Investigation summary: conclusion and justification status: the complaint states revision of right thr - high metal ions.Pain a review of complaint databases did not identify any anomalies.A review of manufacturing records was not required per wi 3430.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN SECTOR HA ACET CUP 54MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 7240911
• Report Number: 1818910-2018-52737
• Device Sequence Number: 16390674
• Product Code: LPH
• UDI-Device Identifier: 10603295009177
• UDI-Public: 10603295009177
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2018

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 Catalogue Number: 121712054
• Device Lot Number: BL3DV1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 01/12/2018; 02/06/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 02/05/2018; 02/08/2018
• 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: 61 YR
• Patient Weight: 85