MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN DELTA BIOLOX HEAD

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: the product has been requested to be returned to zimmer biomet for an investigation.Associated products: medical product: g7 neutral e1 liner 36mm f.Catalogue number: 010000858.Lot number: 6623250.Medical product: tprlc 133 fp 12/14 bm so 11.0.Catalogue number: 51-130110.Lot number: 6616845.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: the patient underwent an initial hip procedure on an unknown date in (b)(6)2020.Subsequently, the patient was revised on (b)(6) 2022, due to thigh pain and instability.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records could not be performed as the item/lot number is unknown.Lot 3108029 does not match delta biolox head the supplier was unable to verify the lot number provided as a zimmer biomet product or a ceramtec product.This device is used for treatment.Insufficient information provided.Unable to perform a compatibility check a review of complaint history could not be performed as the item/lot number is unknown.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues of thigh pain and instability as reported.The reported event has not been confirmed as relevant photographs have not been provided and the product has not been returned for evaluation.The root cause of the reported event cannot be determined with the information provided.Field action search could not be performed as the item & lot number are unknown no corrective actions, preventive actions, or field actions resulted after the investigation of this event.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be tendered accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: the patient underwent an initial hip procedure on an unknown date in (b)(6) 2020.Subsequently, the patient was revised on (b)(6) 2022, due to thigh pain and instability.

• Brand Name: UNKNOWN DELTA BIOLOX HEAD
• Type of Device: UNKNOWN DELTA BIOLOX
• 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: 14039946
• MDR Text Key: 288775016
• Report Number: 3002806535-2022-00209
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• 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: UNKNOWN DELTA BIOLOX HEAD
• Device Lot Number: 3108029
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male