MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 64MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-064
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); No Code Available (3191)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
After review of medical records, the patient was revised for failed right total hip replacement secondary to metallosis, elevated metal levels in the blood stream, trochanteric bursitis with metal debris, and synovitis of the right hip.Operative notes reported, that there was a very white tissue with a slight grayish hue suggestive of metal debris.There was some periacetabular heterotopic bone that was present which was resected.There was some blackened debris around the junction of the morse taper and the femoral head.Morse taper had only mild dulling of the surface or burnishing.Post operative findings reported that a gray metallosis from cobalt chrome, blackening around the ball to morse taper junction as the source of the metal debris.It was also reported that there was a small dehiscence was noted in the capsule posterior superiorly.Doi: (b)(6) 2004; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: PINNACLE 100 ACET CUP 64MM
• 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: 10209500
• Report Number: 1818910-2020-14640
• Device Sequence Number: 19651133
• Product Code: LPH
• UDI-Device Identifier: 10603295008613
• UDI-Public: 10603295008613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1217-01-064
• Device Catalogue Number: 121701064
• Device Lot Number: W3WGA1008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +12; PINNACLE 100 ACET CUP 64MM; PINNACLE MTL INS NEUT36IDX64OD; PRODIGY LG STAT LNG RT 19.5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR