MAUDE Adverse Event Report: BIOMET UK LTD. CER OPT TYPE 1 TPR SLEVE 0MM; CER BIOLOXD OPT TYPE 1 TPR SLV

Model Number N/A

Device Problems Collapse (1099); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient underwent a left hip procedure in 2021.Subsequently, the patient states he is having severe pain, unable to walk and has issues with the hip collapsing and has fallen several times.Patient stated he was hit by drunk driver (b)(6) 2019 and has needed several surgeries over his whole body due to the accident.

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 remains implanted.Associated products: medical product: tprlc xr t1 pps 13x146mm, catalog no.: 51-105130, lot no.: 6258103.Medical product: g7 osseoti 4 hole shell 56mm f, catalog no.: 110010246, lot no.: 64747764.Medical product: g7 neutral arcomxl lnr 40mm f, catalog no.: 010000747, lot no.: 6687449.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00500.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 patient underwent a left hip procedure in 2021.Subsequently, the patient states he is having severe pain, unable to walk and has issues with the hip collapsing and has fallen several times.Patient stated he was hit by drunk driver (b)(6), 2019 and has needed several surgeries over his whole body due to the accident.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: adequate photographs have not been provided and product has not been returned for evaluation.Therefore, 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 device history record (dhr item 650-1058, lot 3039705) has been checked and verifies that the parts were manufactured and sterilised in accordance with the applicable specifications with no deviations or non-conformances found during manufacturing and inspection.A review of the device history record (dhr item 650-1066, lot 3048738) has been checked and verifies that the parts were manufactured and sterilised in accordance with the applicable specifications with no deviations or non-conformances found during manufacturing and inspection.The devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.A review of complaint history (650-1058 complaint history (nov 15, 2018 to nov 15, 2021)) was assessed and identified (5) similar complaints for item #650-1058 (including initiating complaint).There were (0) additional complaints against the lot #3039705.A review of complaint history (650-1066 complaint history (nov 15, 2018 to nov 15, 2021)) was assessed for three years prior to the notification date and identified (3) similar complaints for item #650-1066 (including initiating complaint).There were (0) additional complaints against the lot #3048738.Medical records/radiographs were not provided.The product item no 650-1058 batch 3039705 has not been involved in any previous field actions or capas.The product item no.650-1066 batch 3048738 has not been involved in any previous field actions or capas.No further corrective or preventative actions are required.A definitive root cause cannot be determined.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as the products have 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.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00500-1.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.

• Brand Name: CER OPT TYPE 1 TPR SLEVE 0MM
• Type of Device: CER BIOLOXD OPT TYPE 1 TPR SLV
• 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: 12834465
• MDR Text Key: 280932313
• Report Number: 3002806535-2021-00501
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271489
• UDI-Public: 00887868271489
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 650-1066
• Device Lot Number: 3048738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2020
• 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): Other
• Patient Age: 52 YR
• Patient Sex: Male