MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM MD PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: oxf anat brg lt md size 3 pma, catalog #: 159547, lot #: 707780.Medical product: oxf uni tib tray sz c lm pma, catalog #: 154722, lot #: 348110.Medical product: sig tka gde/mdl set 04-05, catalog #:42-422561, lot #:171816.Medical product: biomet bc r 1x40 us, catalog #: 110035368, lot #: 842eah0505.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00304-1, 3002806535-2021-00320.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 an initial left uni-condylar knee replacement on (b)(6) 2017.The patient began to develop pain and decreased range of motion and despite more conservative interventions was revised on (b)(6) 2019 to a total knee due to microscopic loosening.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: - no product was returned or pictures provided; visual and dimensional evaluations could not be performed.- device is used for treatment.- medical records were provided and reviewed by a health care professional.Review found bone scan shows normal flow, with increased tracer uptake predominantly involving the tibial component.Patient reported pain and decreased rom.Suspected microscopic loosening of the tibial component.Revision performed due to mechanical loosening.- a review of the complaint database over the last 3 years has found 4 complaints reported with the item 159547,6 complaints reported with the item 161469 and 2 complaints reported with the item 154722.- a definitive root cause cannot be determined.- no corrective actions, preventive actions, or field actions resulted after investigation of this event.- this complaint was confirmed.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00304-2 3002806535-2021-00320-1 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.Product not returned.

Event Description

It was reported the patient underwent an initial left uni-condylar knee replacement.The patient began to develop pain and decreased range of motion and despite more conservative interventions and was revised to a total knee due to microscopic loosening.

• Brand Name: OXF TWIN-PEG CMNTD FEM MD PMA
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12209659
• MDR Text Key: 262864643
• Report Number: 3002806535-2021-00319
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438242
• UDI-Public: (01)05019279438242(17)270220(10)196210
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• 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: 161469
• Device Lot Number: 196210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82