MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN FINGER IMPLANT

Catalog Number UNK FINGER

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199); No Code Available (3191)

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

Silicone metacarpophalangeal arthroplasty for osteoarthritis: long-term results.Update 27 aug 2019.¿silicone metacarpophalangeal arthroplasty for osteoarthritis: long-term results¿ was reviewed for mdr reportability.The study followed 35 patients (40 implants) who underwent surgery for metacarpophalangeal osteoarthritis.The average follow-up was 8.3 years with an average patient age of 58 years old.It is noted specific patient identifiers nor specific revision information was provided.The following adverse events were noted: there was only one reported revision.Reason for revision was not specified.There were 5 cases of post-operative implant fracture without evidence of instability, pain, decreased range of motion, or symptoms of synovitis.The final average pain score (scale, 0-10) was 0.3 of 10.

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 : the device associated with the reported event was not returned to the investigation site for evaluation.Review of x-ray images and photographs did not reveal any evidence of product malfunction or error.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 : null.Device history batch : null.Device history review : null.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 FINGER IMPLANT
• Type of Device: FINGER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9030566
• MDR Text Key: 162795394
• Report Number: 1818910-2019-104405
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FINGER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention