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

Model Number N/A

Device Problems Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)

Event Date 01/20/2023

Event Type  Injury  

Event Description

It was reported that approximately year after partial right knee arthroplasty patient experienced cracking, popping and pain.Bone scan showed loosening.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10: concomitant medical products: item reference: unknown, item name: unknown oxford tibial component right, item lot: unknown.Item reference: unknown, item name: unknown oxford bearing right, item lot: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00148 and 3002806535-2023-00150.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.H3 other text: product data and product not available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, d4, d9, d10, g1, g3, g6, h1, h2, h3,h4, h6, h10.D10: associated products: associated product: item reference: 159577, item name: oxf anat brg rt md size 5 pma , item lot: 056400, item reference: 154725, item name: oxf uni tib tray sz d rm pma, item lot: 345720, item reference: 110035368, item name: biomet bc r 1x40 us, item lot: h2203z36ba.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 that could be related to the reported event.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.The earlier images demonstrate bilateral medial unicompartmental arthroplasties with anatomic alignment, subsequent images 19 months post implantation demonstrate new radiolucency at the medial margin of the right knee tibial implant bone-metal interface consistent with osteolysis and early implant loosening.Overall alignment is maintained.Interval development of osteolysis and early implant loosening of the right knee medial unicompartmental arthroplasty.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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.D10: associated products: item reference: 159577, item name: oxf anat brg rt md size 5 pma , item lot: unknown.Item reference: 154725, item name: oxf uni tib tray sz d rm pma, item lot: unknown.

Event Description

It was reported that approximately two years after initial bilateral partial knee replacements the patient presented with pain and stiffness in bilateral knees, right greater than left.Bone scans and xrays revealed right knee radiolucency under the tibial baseplate concerning for loosening.A revision to right total knee replacement was discussed with the patient, but none has been scheduled at this time.Due diligence is in progress for this complaint; to date no additional information or product has been received.

• Brand Name: OXF TWIN-PEG CMNTD FEM MD PMA
• Type of Device: 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: 16960689
• MDR Text Key: 315537522
• Report Number: 3002806535-2023-00149
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438242
• UDI-Public: (01)05019279438242(17)300324(10)176040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 161469
• Device Lot Number: 176040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 107 KG