MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ B LM PMA; OXFORD CEMENTED TIBIAL TRAYS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Associated products: medical product: unknown palacos bone cement.Catalog no.: unknown.Lot no.: unknown.Medical product: unknown 3mm oxford bearing.Catalog no.: unknown.Lot no.: unknown.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00309 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient underwent a left partial knee on (b)(6) 2018.Subsequently, the patient claims to have pain and loosening for the past four years and will require a revision.

Manufacturer Narrative

(b)(4) complaint summary: as the product has not been received, the investigation was limited to the information provided and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 8 complaints reported with the item 161469 and 2 complaints reported with the item 154720 (including initiating complaint).Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00309-1 if any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported the patient underwent a left partial knee on (b)(6)2018.Subsequently, the patient claims to have pain and loosening for the past four years and will require a revision.

• Brand Name: OXF UNI TIB TRAY SZ B LM PMA
• Type of Device: OXFORD CEMENTED TIBIAL TRAYS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12172774
• MDR Text Key: 261678077
• Report Number: 3002806535-2021-00310
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154720
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 77