MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE -3; HIP PROSTHESIS

Model Number	650-1065
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Ambulation or Postural Difficulties (2544)
Date of Event	04/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: cer bioloxd option hd 36mm; item# 650-1057; lot# 3102327.G7 vit e neutral lnr 36mm f; item# 30103606; lot# 65596487.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00157.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision procedure approximately 6 months post implantation due to a fall.The patient was no longer stable due to tissue damage.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -3
• Common Device Name: HIP PROSTHESIS
• 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: 16983269
• Report Number: 3002806535-2023-00152
• Device Sequence Number: 6852647
• Product Code: LZO
• UDI-Device Identifier: 00887868271472
• UDI-Public: (01)00887868271472(17)320908(10)3130574
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 650-1065
• Device Catalogue Number: 650-1065
• Device Lot Number: 3130574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male