MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-03-052
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	11/12/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.(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
Unf and medical records received.After review of medical records, the patient complains of worsening right hip and groin pain and had increased metal ions, as well as cross-table lateral of the pelvis showing increased anteversion potentially leading to edge loading.The patient was then revised for right metal on metal total hip.Total hip arthroplasty with elevated metal ions.Operative notes reported that there was noted to be metallosis around the surrounding soft tissues even prior to entering in the capsule.There was noted to be a significant amount of greenish black soft tissue debris.The taper was examined and there was a slight amount of grayish material consistent with a small amount of taper corrosion, but overall the taper looked fine.There was some scuff marks on the posterior lateral aspect of the of neck of the prosthesis possibly due to impingement on the posterior aspect of the acetabular component.The acetabulum appeared to be significantly anteverted.There was no significant bony ingrowth on the cup.Doi: (b)(6) 2007; dor: (b)(6) 2012; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. this is a duplicate report of mfr# 1818910-2018-77583.Mfr# 1818910-2020-05632 is being retracted as it a report duplication.Mfr# 1818910-2018-77583 will be kept for investigation purposes.

• Brand Name: PINNACLE 300 ACET CUP 52MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9739178
• Report Number: 1818910-2020-05632
• Device Sequence Number: 3098495
• Product Code: LPH
• UDI-Device Identifier: 10603295008651
• UDI-Public: 10603295008651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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 Model Number: 1217-03-052
• Device Catalogue Number: 121703052
• Device Lot Number: BE8E91000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/03/2020
• 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: 56 YR