MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.

Event Description

Pinnacle litigation records received.Litigation records alleges pain, weakness, swelling, numbness, bone, loss of mobility, loss of range of motion, and walking difficulty.During clinic visit on (b)(6) 2013 patient underwent diagnostic blood testing and the cobalt and chromium levels were within normal levels.Another clinic visit on (b)(6) 2019 patient underwent diagnostic of a 3-phase bone scan which revealed loosening of the depuy pinnacle system which would confirm and validated, required for revision surgery.Doi: (b)(6) 2013 : dor: none reported (left hip).

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1, h6 (health effect - impact code & medical device problem code).

Event Description

Medical records received.Update ad 10 may 2022 additional information received from aei note a-7313983.Ppf,pfs and medical records received.In addition to what previously alleged, ppf alleged loosening of cup and stem.Pfs has no new allegation reported.After review of medical records patient was revised was due to failed total hip arthroplasty.Operative notes indicated some lucencies around the proximal femur, metal wear.There were some debris and some lysis related to the stem or related to the articulation.The femoral component was impacted into the femoral canal in about 5 degrees of anteversion.Doi: (b)(6) 2013.Dor: (b)(6) 2020.Left hip.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.No photo evidence of the device was attached.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a device history record (mre) review was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11476096
• MDR Text Key: 239723196
• Report Number: 1818910-2021-05024
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/25/2021

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 Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 05/10/2022; 07/15/2022
• Supplement Dates FDA Received: 05/13/2022; 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CORAIL SIZE 16 HIGH OFFSET COLLARLESS STEM; METAL FEMORAL HEAD 40MM; METAL LINER 48X50; PINNACLE CUP 40X56MM
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male