MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; BIOLOX DELTA CERAMIC OPTION HD

Model Number N/A

Device Problem Human-Device Interface Problem (2949)

Patient Problem Unspecified Infection (1930)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign: event occurred (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: initial right hip hemiarthroplasty was performed on (b)(6) 2017 in a (b)(6) female.Subsequently, the patient was revised on (b)(6) 2017 due to infection.Patient involvement: revision.

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 and a complaint history search a review of complaint history identified one additional similar complaint about the reported item number.A historical search of the lot number could not be performed as it has not been provided.This device is used for treatment.The implants used have been confirmed to be compatible.A manufacturing history review could not be performed as the lot number has not been provided.The likely condition of the device when it left zimmer biomet could not be determined as the lot number has not been provided.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.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: initial right hip hemiarthroplasty was performed on (b)(6) 2017 in an 85-year-old female.Subsequently, the patient was revised on (b)(6) 2017 due to infection.Patient involvement-revision.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: BIOLOX DELTA CERAMIC OPTION HD
• 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: 14186157
• MDR Text Key: 289859581
• Report Number: 3002806535-2022-00226
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: 00887868271373
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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: 650-1055
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention