MAUDE Adverse Event Report: BIOMET UK LTD. CER OPT TYPE 1 TPR SLEVE 0MM; 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 3002806535 - 2024 - 00010 investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that 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.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.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 OPT TYPE 1 TPR SLEVE 0MM
• 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: 18474445
• MDR Text Key: 332429676
• Report Number: 3002806535-2024-00009
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00887868271489
• UDI-Public: (01)00887868271489(17)301112(10)3048736
• 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: 650-1066
• Device Lot Number: 3048736
• 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: 11/12/2020
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose