MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX60OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-460

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body In Patient (2687); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530)

Event Date 07/27/2020

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

Unf and medical records received.Pinnacle claim submission form alleges elevated metal ions and metallosis/metal wear.After review of medical records patient was revised to address failed right total hip replacement.Revision notes reported that we clearly noted that the soft tissue lining the hip might have slightly darkened from metal wear, but that significantly was far from black.We did have corrosion at the trunnion.We were able to explant the size 40 diameter femoral head, immediately noted the trunnion had mild corrosion.Doi: (b)(6) 2008; dor: (b)(6) 2020; (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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINNACLE MTL INS NEUT40IDX60OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10818979
• MDR Text Key: 215612228
• Report Number: 1818910-2020-24365
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: 1218-87-460
• Device Catalogue Number: 121887460
• Device Lot Number: 2594872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/13/2020; 09/26/2023
• Supplement Dates FDA Received: 11/16/2020; 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM; TRI-LOCK BPS SZ 6 HI OFFSET; 12/14 ARTICUL 40MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX35MM; PINN CAN BONE SCREW 6.5MMX40MM; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM; TRI-LOCK BPS SZ 6 HI OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male