MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US METAGLENE GUIDE PIN DIA 2.5MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Catalog Number 230787004

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Removal of infected shoulder prosthesis, surgeon, (b)(6) hospital (b)(6) 2019.History of painful shoulder.Clinical markers indicate infection, according to surgeon.All components removed, which were quite loose (both humeral and glenoid), then discarded.Biomet shoulder antibiotic cement spacer placed insitu.

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: METAGLENE GUIDE PIN DIA 2.5MM
• Type of Device: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; b.p. 256; warsaw IN 46581 0988
• MDR Report Key: 8696967
• MDR Text Key: 147932659
• Report Number: 1818910-2019-95923
• Device Sequence Number: 1
• Product Code: HSD
• 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
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230787004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR