MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE +6; CER BIOLOXD OPT TYPE 1 TPR SLV

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.The product has not been returned to zimmer biomet for investigation.Medical product: cer bioloxd option hd 32, catalog #: 650-1056, lot #: 2886436 multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00177 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported by legal counsel that a patient underwent a left hip arthroplasty on (b)(6) 2016.By (b)(6) 2017 the patient began experiencing pain while walking.After a 3d radiographic diagnostic revealed a defect of hardware.Subsequently the patient was revised.During the (b)(6) 2017 procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.
Event or Problem Description
It was reported by legal counsel that a patient underwent a left hip arthroplasty on (b)(6) 2016.By (b)(6) 2017 the patient began experiencing pain while walking.After a 3d radiographic diagnostic revealed a defect of hardware.Subsequently the patient was revised.During the (b)(6) 2017 procedure, inspection of the joint space showed that there were multiple fragments of polyethylene, that the prosthetic femoral head was articulating with the acetabular shell, and that there was striping over the weight bearing portion.All products were revised.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 complaints reported with the item 650-1056 and 1 complaint reported for the item 650-1068 including initiating complaint.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00177-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : product not returned.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE +6
• Common Device Name: CER BIOLOXD OPT TYPE 1 TPR SLV
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11805429
• Report Number: 3002806535-2021-00178
• Device Sequence Number: 3909167
• Product Code: OQG
• UDI-Device Identifier: 00880304521902
• UDI-Public: 0880304521902
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 650-1068
• Device Lot Number: 646810
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention