MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM LG PMA; OXFORD CEMENTED FEMORALS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00493, 3002806535-2021-00495.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 that a patient underwent an initial right knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2021.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.We have been informed that the revision was due to pain and lateral wear.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00493-1, 3002806535-2021-00495-1.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 that a patient underwent an initial right knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure due to pain and lateral wear was performed on (b)(6) 2021.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: adequate photographs have not been provided and the product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, an x-review and a complaint history search.The manufacturing history records (mhrs) of the tibial tray, meniscal bearing and femoral component have been checked and verified that the parts were manufactured and sterilised in accordance with the applicable specifications.Three radiographs were provided with (b)(4): one mediolateral (ml), one bilateral anteroposterior (ap), and one sunrise radiograph.All provided radiographs are dated (b)(6) 2021, approximately 8 years after primary surgery, and approximately 11 weeks before revision.Immediate post-primary surgery radiographs have not been provided and are required in order to fully assess the initial size, position and alignment of the components.The provided ml radiograph shows the presence of large debris in the posterior joint space, which may be an osteophyte or a fragment of bone or bone cement.A small gap is visible between the tibial tray and the tibial plateau in both the posterior and the anterior region, as well as between the femoral component and the femur in the posterior region.The orientation of the knee in the provided ap radiograph does not allow for the full assessment of component fit and positioning.The oxford partial knee surgical technique recommends to, before taking the film, adjust the position of the limb by flexing/extending the knee and internally/externally rotating the leg until the tibial component appears on the screen directly end-on.Bone density of the proximal tibia appears to be below, in particular below the medial portion of the tibial tray, as well as around the keel.Osteophytes may be present around the medial edge of the tibial plateau.The patient experience report (per) informs that the patient is male, weighs 108.41 kg and is 170.18 cm tall, therefore his bmi is 37.4 (obese).Activity levels or contributing conditions were not reported.Surgical notes were not provided.Review of complaint history identified: 3 additional similar complaints about the reported item 154776 and no additional complaints about the reported item and lot combination.7 similar complaints about the reported item 161470 and no additional complaints about the reported item and lot combination.5 additional similar complaints about the reported item 159583 and no additional for the reported item and lot combination.These devices are used for treatment.The reported items are compatible.It has been confirmed that the implants are not within the scope or subject of any field actions or recalls which could be attributed to the reported events.Based on the available information, it appears that the patient¿s high bmi and bone quality may have contributed to the reported pain and lateral wear.Other potential contributing factors cannot be discussed without examination of the revised components, which were discarded during revision surgery, and without provision of additional radiographic, patient and surgical information.The likely condition of the devices when they left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided and the product has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.Corrective or preventative action is not required.The root cause of the reported event cannot be determined with the information provided.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00493-2, 3002806535-2021-00495-2.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported, that: a patient underwent an initial right knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure due for unknown reasons was performed on (b)(6)2021.Oxford warranty case.Conversion to total knee arthroplasty.Patient outcome: revision.Addi (b)(6) 2022.1.Reason for the revision.Pain and lateral wear.2.Were there any patient-specific indications that could have led to the revision? i don¿t know.3.Operative notes, both initial and revision (as applicable)? i sent all i had available.4.Name of the hospital where the initial procedure was performed? i don¿t know.5.Name of the surgeon who performed the initial procedure? i don¿t know.

• Brand Name: OXF TWIN-PEG CMNTD FEM LG PMA
• Common Device Name: OXFORD CEMENTED FEMORALS
• 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: 12810997
• Report Number: 3002806535-2021-00494
• Device Sequence Number: 17300542
• Product Code: NRA
• UDI-Device Identifier: 05019279438259
• UDI-Public: 05019279438259
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2022

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: 05/21/2023
• Device Model Number: N/A
• Device Catalogue Number: 161470
• Device Lot Number: 336810
• 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: 11/08/2021
• Supplement Date Received by Manufacturer: 01/14/2022; 03/30/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/19/2022; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2013
• 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 Age: 69 YR
• Patient Sex: Male