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 Problems Cyst(s) (1800); Pain (1994); Osteolysis (2377)

Event Date 12/14/2021

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

This case is to capture the implant required that is custom made implant required for an upcoming revision.The pc reference is required to order the custom implant.Surgeon has a patient with a mobility ankle replacement, patient had a peri-prosthetic fracture at some point with resulting osetolysis and now requires a bearing exchange.Doi: (b)(6) 2012.Dor: (b)(6) 2021; unknown side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination, however some photos were provided.Upon visual inspection of the photos, no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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: 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 IRELAND 9616671; loughbeg ringaskiddy co.; cork LS11 8 DT; EI LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13152290
• MDR Text Key: 283152649
• Report Number: 1818910-2022-00074
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955505403
• Device Lot Number: 3353219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MOB ANKLE BEARING 4 X 3MM.; UNKNOWN ANKLE TIBIAL.
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 80 KG