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

Catalog Number UNK SHOULDER HUMERAL HEAD

Device Problem Corroded (1131)

Patient Problem No Code Available (3191)

Event Date 06/01/2016

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 ¿fretting and corrosion in modular shoulder arthroplasty: a retrieval analysis¿ by johannes a.Eckert, ulrike mueller, sebastian jaeger, benjamin panzram, and j.Philippe kretzer, published in hindawi, june 1, 2016, was reviewed.The purpose was to evaluate tribocorrosion in the retrieval of anatomic shoulder implants upon revision.There were a total of 38 consecutively retrieved anatomic implants for analysis.Out of those 38, four belonged to depuy synthes.It was determined that tribocorrosion was present on 27 of 36 heads (two were excluded from the study).Despite seeing tribocorrosion in the majority of the retrieved implants, only a small subset of 16% showed moderate to severe corrosion for both tapers; most prosthesis featured only mild tribocorrosion.The article did not specify which implants had which degree of tribocorrosion, however did reports it was noted more in mixed metal combinations (ti-cocr).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: 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 code(s) was not provided.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.Corrective action was not indicated.If information is obtained that was not available for the initial 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: 9322097
• MDR Text Key: 182473016
• Report Number: 1818910-2019-115542
• 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
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• 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
• Device Lot Number: UNKNOWN
• 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