MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER LNR 32MM C; HIP ARTHROPLASTY

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 04/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the g7 deltaliner, which was implanted on (b)(6) 2019, underwent replacement surgery on (b)(6) 2021 due to fracture.There was a report that it was damaged because it was not fixed properly at the time of implant.

Manufacturer Narrative

Cmp- (b)(4).This final report is being submitted, to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided.A review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation, which could provide additional information.A review of the manufacturing history records confirms, no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 1 complaint reported with item 110003616 (which is the initiating complaint).With the limited information received the root cause of the reported event could not be determined, however is was noted that the item was damaged because it was not fixed properly at the time of implant.This could be a contributing factor to the implant fracture.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.If any further information is found, which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3: other text: product location unknown.

Event Description

It was reported, that the g7 delta liner, which was implanted on (b)(6) 2019, underwent replacement surgery on (b)(6) 2021, due to fracture.There was a report, that it was damaged, because it was not fixed properly at the time of implant.

• Brand Name: BIOLOX DELTA CER LNR 32MM C
• Type of Device: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11982156
• MDR Text Key: 255605404
• Report Number: 3002806535-2021-00255
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 05019279494354
• UDI-Public: (01)05019279494354(17)290513(10)6547349
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• 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: 110003616
• Device Lot Number: 6547349
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention