MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number N/A

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

Patient Problems Fall (1848); Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 ¿ medical devices: cer opt type 1 tpr sleve 0mm; item# 650-1066; lot# 3048736.Cer bioloxd option hd 36mm; item# 650-1057; lot# 3103921.G7 osseoti multihole 56mm f; item# 110010266; lot# 65300747.Trilogy bone scr 6.5x35; item# 00-6250-065-35; lot# j7258386.Trilogy bone scr 6.5x25; item# 00-6250-065-25; lot# j7263672.3.2mmx30mm rnglc+ acet drl bit; item# 31-323230; lot# 495410.G7 apical hole plug; item# 010000994; lot# 7130450.G7 vit e 10deg lnr 36mm f; item# 30113606; lot# 65312681.3.2mmx40mm rnglc+ acet drl bit; item# 31-323240; lot# 457220.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2024-00009.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported by the patient underwent a hip arthroplasty surgery.Subsequently the patient is being revised due to a fall and poor bone quality.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Limited investigations do not need to have the raw material certificate, sterilization certificate, complaint history, product hold/field action pulled and reviewed.Also, a review of the risk management file has not been completed as the product is considered unrelated to the reported event.Complaints are monitored per sop263 complaint trending process.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.The root cause of the reported issue is unrelated to the zimmer biomet medical device.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 18474452
• MDR Text Key: 332429802
• Report Number: 3002806535-2024-00010
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271397
• UDI-Public: (01)00887868271397(17)320228(10)3103921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 3103921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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
• Patient Sex: Prefer Not To Disclose