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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Hyperextension (4523)

Event Date 01/11/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00013, 3002806535-2022-00015.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure converting an oxford bearing due to pain and hyperextension (recuvatum) and collapsed tibia was performed on (b)(6) 2022.No delay reported.

Event Description

It was reported, that: a patient underwent an initial right knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure converting an oxford bearing due to pain and hyperextension (recuvatum) and collapsed tibia was performed on (b)(6) 2022.No delay.Patient outcome: revision.Was the surgical technique for the product utilized: yes.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation.X-rays or medical notes have not been provided.The investigation has been limited to the information provided, a review of the device history records, and a complaint history search.A review of the manufacturing history records confirms no abnormalities or deviations were reported.A review of the complaints database for 3 years before the notification date has identified the following information: one (1) similar complaint about item#: 159568 (including the initiating complaint).No additional search against the lot number was required as this complaint was the only record of revision due to pain against the item number.Five (5) similar complaints about item#: 161468 (including the initiating complaint).There were zero (0) additional complaints against lot#: 127080.Three (3) similar complaints about item#: 154719 (including the initiating complaint).No additional search against the lot number was required as this complaint was the only record of revision due to pain against the item number.These devices are used for treatment.The implants used have been confirmed to be compatible.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the devices when they left zimmer biomet is conforming to the specification.The root cause of the reported event can not be determined with the information provided.No corrective action is required at this time as the root cause of the reported event has not been determined.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00013-1, 3002806535-2022-00015-1.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.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Type of Device: 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: 13306457
• MDR Text Key: 284115322
• Report Number: 3002806535-2022-00014
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438228
• UDI-Public: 05019279438228
• 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
• Report Date: 03/29/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161468
• Device Lot Number: 127080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 112 KG