MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PINNACLE MTL INS NEUT36IDX64OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-364

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Test Result (2695); No Code Available (3191)

Event Date 02/12/2018

Event Type  Injury  

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 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.

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 MTL INS NEUT36IDX64OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10209494
• MDR Text Key: 197112905
• Report Number: 1818910-2020-14642
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2010
• Device Model Number: 1218-87-364
• Device Catalogue Number: 121887364
• Device Lot Number: 1079108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR