MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; KNEE PROSTHESIS

Catalog Number UNKNOWN OXFORD BEARING

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Literature: panzram b, bertlich i, reiner t, walker t, hagmann s, weber m-a, et al.(2017) results after cementless medial oxford unicompartmental knee replacement - incidence of radiolucent lines.Plos one12(1): e0170324.Https://doi.Org/10.1371/journal.Pone.0170324.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Current information is insufficient to permit conclusion as to the cause of the event.

Event Description

It has been reported in a journal article that a patient underwent a knee replacement procedure.Subsequently, a mobile-bearing dislocation occurred 21 months after initial surgery.The 4 mm bearing was exchanged to a 5 mm one.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7048529
• MDR Text Key: 92621289
• Report Number: 3002806535-2017-01071
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN OXFORD BEARING
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention