MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Fibrosis (3167)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information received indicates the revision was for a metal on metal pinnacle construct implanted in the left hip.There was no indication of revision for the patient's right hip asr prosthesis.If/when additional information is received, the complaint will be updated and a supplemental med watch report will be submitted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to treat foreign body reaction and fibrosis secondary to metal abrasion of the liner and femoral head.Upon entering the joint, the foreign body reaction was confirmed and brown discolored tissue was excised.The liner, head, and stem were removed.Doi: 2017; dor: (b)(6) 2021; left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device did not identify any product defects or anomalies.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot: a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.H10 additional narrative:  h6 medical device problem code: appropriate term/code not available (a27) used to capture incident.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device did not identify any product defects or anomalies.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11912178
• MDR Text Key: 253498160
• Report Number: 1818910-2021-11400
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2021

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 FEMORAL HEAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/01/2021; 06/18/2021; 06/21/2021
• Supplement Dates FDA Received: 06/17/2021; 06/21/2021; 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINNACLE MTL INS NEUT36IDX52OD; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; PINNACLE MTL INS NEUT36IDX52OD; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR