MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 5 PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Swelling/ Edema (4577)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial oxford pks, and approximately 10 months post op underwent a revision due to poly spin out (dislocation).Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.D10 - oxf twin-peg cmntd fem md pma, item 161469, lot 599900.Oxf uni tib tray sz b rm pma, item 154751, lot 129340.The product was not returned.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: no contributing factors were noted.Patient presents with high level, swelling, pain with activities, night pain, clicking, instability.Significant pain during stretching routines.Limited range of motion.Palpable lump medial to her right patella and joint line.Mri showed full-thickness medial chondral loss and some partial-thickness areas of chondromalacia in the patellofemoral and lateral compartments.X-rays show loss of space in the medial joint line between the tibial and femoral components, possibly displaced plastic component.During revision, the anterior dislocation of the poly was noted, tibial and femoral components were well fixed.Mcl was intact, no other abnormalities were noted.Poly exchange performed without complication.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.
Event or Problem Description
It was reported that the patient underwent an initial right unicompartmental knee arthroplasty.The patient did well until she presented to the clinic 10 months postop with pain, swelling, and instability.Subsequently, the patient underwent a poly exchange due to dislocation of the mobile bearing.During the revision, the tibial and femoral implants were noted to be well-fixed, and the bearing was exchanged without complications.

• Brand Name: OXF ANAT BRG RT MD SIZE 5 PMA
• Common Device Name: KNEE PROSTHESIS
• 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: 16231616
• Report Number: 3002806535-2023-00019
• Device Sequence Number: 17860290
• Product Code: NRA
• UDI-Device Identifier: 05019279786237
• UDI-Public: (01)05019279786237(17)260628(10)613990
• 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: 2022
• 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): 03/14/2023

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: Health Professional
• Device Expiration Date: 06/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 159577
• Device Lot Number: 613990
• 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: 01/10/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 68 KG