MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB BRG MED SZ4; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 01/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).As the device is still at this time implanted it is unknown to zimmer biomet whether it will be returned for an investigation, once this information is known it will be provided in a supplementary report.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: at the stairs, sudden cracking noise with subsequent evidence of inlay fracture.Bfarm case number: (b)(4).Patient outcome: serious injury.Will require a revision.

Event Description

It was reported, that: at the stairs, sudden cracking noise with subsequent evidence of inlay fracture.Bfarm case number: (b)(4).Patient outcome: serious injury.04 mar 2022 addi.Implant can't be found.11 mar 2022 addi.The prosthesis was implanted by dr (b)(6) on (b)(6) 2006.Implant documentation is attached.Op report and perioperative x-rays are available.The date of revision surgery with inlay change was (b)(6) 2022.Implant documentation is attached.The implant was not sent to me and is washed but not sterilised.There are no other risk factors, primary wear is assumed.The surgical technique was of course followed.

Manufacturer Narrative

(b)(4).This follow-up document is being submitted to relay supplemental information.Supplemental information acquired: implant date.Explant date.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be tendered.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the device is used for treatment.The product item no.154627 lot: 1113952 has not been involved in any previous capas or field actions.A review of the manufacturing history record confirms that the device was manufactured, processed and verified in line with the specification & quality characteristics as defined by zimmer biomet.No corrective actions are required at this time.The definitive root cause cannot be determined with the available information.The device was originally implanted on (b)(6) 2006 with the reported event occurring on (b)(6) 2022.Numerous factors such as accidental damage or wear could have contributed to the failure of the device during the 16 years that it had been in use, however, the length of time in service before the complaint was reported suggests that the device was conforming at the time of distribution by zimmer biomet.The investigation is completed based on currently available information.The product was not returned after 3 requests.The customer confirmed that unfortunately, the implant can no longer be found.If any additional information becomes available, then the complaint will be reopened and investigated further.The hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The overall risk is considered low.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 Description

It was reported, that: at the stairs, sudden cracking noise with subsequent evidence of inlay fracture.Bfarm case number: (b)(4).Patient outcome: serious injury.

• Brand Name: OXFORD UNI TIB BRG MED SZ4
• Type of Device: OXFORD HXLPE BEARINGS
• 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: 13557942
• MDR Text Key: 285801786
• Report Number: 3002806535-2022-00071
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2010
• Device Model Number: N/A
• Device Catalogue Number: 154627
• Device Lot Number: 1113952
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2005
• 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 Age: 85 YR
• Patient Sex: Male