MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C LM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
Additional 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 twin-peg cmntd fem md pma, catalog #: 161469, lot #: 196210.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- 00319.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem 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.
Additional 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, 3002806535-2021-00319-1.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.H3 other text : product not returned.
Event or Problem 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 UNI TIB TRAY SZ C LM PMA
• Common Device Name: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12209651
• Report Number: 3002806535-2021-00320
• Device Sequence Number: 11714117
• Product Code: NRA
• UDI-Device Identifier: 05019279388882
• UDI-Public: (01)05019279388882(17)260602(10)348110
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 154722
• Device Lot Number: 348110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 82