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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRIAL BEARING MED SZ 4/5; KNEE ARTHROPLASTY
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BIOMET UK LTD. OXF TRIAL BEARING MED SZ 4/5; KNEE ARTHROPLASTY Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Initial report.Product has been requested to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that after cementing the tibial and the femoral component a 4mm gauge was inserted until the cement hardened.A 4mm trial bearing was used to check the stability before proceeding the real implant, then trialled the 5mm.Subsequently, the instrument broke off (where the threaded portion screws into the plastic trial).The blue trial was removed with a towel clip.Once removed the wound was irrigated and inserted the real implant.This tray was not consigned to the hospital it was a loaner tray.No delay of the procedure reported.No clinical signs, symptoms or conditions were reported.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10 additional information received: product lot number received: 299603 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that after cementing the tibial and the femoral component a 4mm gauge was inserted until the cement hardened.A 4mm trial bearing was used to check the stability before proceeding the real implant, then trialled the 5mm.Subsequently, the instrument broke off (where the threaded portion screws into the plastic trial).The blue trial was removed with a towel clip.Once removed the wound was irrigated and inserted the real implant.This tray was not consigned to the hospital it was a loaner tray.No delay of the procedure reported.No clinical signs, symptoms or conditions were reported.
 
Manufacturer Narrative
(b)(4).Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.Visual inspection confirmed that the handle had separated from the 5mm trial bearing.There is also evidence of heavy wear and damage to the bearing.Review of the certificates of conformance from both the manufacturer (symmetry medical [othy]) and the raw material supplier (westlake plastics company) confirms that the material complies to required requirements of the specification.A review of complaint history was assessed for three years prior to the notification date and identified (3) total complaints about item 32-4203784.There were (0) additional complaints against the lot 299603.The most likely root cause is expected wear and tear due to the time spent in the field (approximately 16 years).The hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The risk is considered to be negligible.
 
Event Description
It was reported that after cementing the tibial and the femoral component a 4mm gauge was inserted until the cement hardened.A 4mm trial bearing was used to check the stability before proceeding the real implant, then trialled the 5mm.Subsequently, the instrument broke off (where the threaded portion screws into the plastic trial).The blue trial was removed with a towel clip.Once removed the wound was irrigated and inserted the real implant.No delay of the procedure reported.No clinical signs, symptoms or conditions were reported.
 
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Brand Name
OXF TRIAL BEARING MED SZ 4/5
Type of Device
KNEE ARTHROPLASTY
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key11472786
MDR Text Key245200623
Report Number3002806535-2021-00078
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number32-420378
Device Lot Number299603
Was the Report Sent to FDA? No
Date Manufacturer Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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