MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN SHOULDER HUMERAL HEADS

Catalog Number UNK SHOULDER HUMERAL HEAD

Device Problem Corroded (1131)

Patient Problems Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled ¿tribocorrosion in shoulder arthroplasty humeral component retrievals¿ by matthew g.Teeter, phd; michael j.Carroll, md, frcsc; gilles walch, md; and george s.Athwal; published in the journal of shoulder and elbow surgery, 2016, was reviewed.The article¿s purpose was to evaluate the presence of tribocorrosion in retrieved humeral total and hemiarthroplasty modular implants.We hypothesized that we would see mild or no corrosion or fretting damage at the modular connections of shoulder arthroplasty retrieval implants.There were 28 implants explanted, two were ap, depuy.The rest were competitors.Out of the two depuy ap implants, there was no evidence of corrosion on the connector, but one had mild fretting on both the head and stem sides this implant was explanted because of infection.The second one, was revised due to implant instability.The implant had mild corrosion on the head side of the connector but no corrosion on the stem side and had no visible signs of fretting on either connector side.

Manufacturer Narrative

Product complaint # (b)(4).Patient code: not applicable ((b)(4)) used to capture medical device removal.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER HUMERAL HEADS
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9328287
• MDR Text Key: 183041171
• Report Number: 1818910-2019-114385
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention