MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 MOB ANKLE BEARING 4 X 3MM; MOBILITY ANKLE SYSTEM : ANKLE TIBIAL

Catalog Number 955505403

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 12/13/2021

Event Type  malfunction  

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

Polyethylene material appears to be wore on implant per x-ray examination of ankle joint.Original replacement completed 10-15 years ago.

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.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

A.Please confirm the date of revision.- patient has not yet been revised.This product complaint was required to be raised in order for the custom ankle bearing to be ordered.B.Was surgery time extended? if yes, what was the duration of the delay? - n/a c.Please provide product details of the explanted depuy implants.- revision surgery has not yet occurred.D.Please confirm the affected side involved in this event.- tba e.Please confirm if the explanted products are available for return.- revision surgery has not yet occurred.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: MOB ANKLE BEARING 4 X 3MM
• Type of Device: MOBILITY ANKLE SYSTEM : ANKLE TIBIAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13094631
• MDR Text Key: 283332237
• Report Number: 1818910-2021-28846
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955505403
• Device Lot Number: 2678942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/12/2022; 02/14/2022
• Supplement Dates FDA Received: 01/20/2022; 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1