MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 3 PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Osteopenia/ Osteoporosis (2651)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right unilateral (medial side) partial knee replacement.Subsequently, was revised to a total knee six months later due to pain, difficulty with ambulation, and extensive radiolucency along the tibial implant which appears loose and subsided laterally.There is also suspected lucency along the femoral implant without frank loosening.Bone quality is markedly osteopenic.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10 ¿ oxf twin-peg cmntd fem sm pma, item# 161468 , lot# 635200.Oxf uni tib tray sz c rm pma, item# 154723, lot# 65717233.Unknown cement, item# unknown, lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00234; 3002806535 - 2023 - 00235.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
No further event information available at the time of this report. .
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device/s are used for treatment.Radiographs were provided and reviewed by a radiologist.Medial unicompartmental arthroplasty with tibial implant loosening and lateral subsidence.Marked osteopenia.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 RT SM SIZE 3 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: 17296145
• Report Number: 3002806535-2023-00236
• Device Sequence Number: 6174377
• Product Code: NRA
• UDI-Device Identifier: 05019279786145
• UDI-Public: (01)05019279786145(17)270728(10)164880
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/26/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 164880
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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 Sex: Female
• Patient Weight: 84 KG