MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 4 PMA; KNEE PROTHESIS

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ oxf uni tib tray sz c lm pma item#154722 lot#unknown.Oxf twin-peg cmntd fem sm pma item#161468 lot#unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent revision surgery due mobile bearing dislocation.During the revision valgus laxity was noted in extension and 20 degrees flexion.The mobile bearing was replaced without complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were provided and reviewed by a health care professional, valgus laxity was noted in extension and 20 degrees flexion, some degree of mcl injury noted and improved stability noted with size 7 insert.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OXF ANAT BRG LT SM SIZE 4 PMA
• Common Device Name: KNEE PROTHESIS
• 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: 17331394
• Report Number: 3002806535-2023-00248
• Device Sequence Number: 6617535
• Product Code: NRA
• UDI-Device Identifier: 05019279785872
• UDI-Public: (01)05019279785872
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 70 KG