MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 36MM; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cmp(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted (b)(4).Part: unknown sleeve, lot: unk.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00552.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 that the patient underwent a revision due to unknown reasons.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that the patient underwent a revision due to unknown reasons.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) this final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00552-1.Only product (item: 650-1057, name: cer bioloxd option hd 36mm) has been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.The most likely root cause of the superficial marks on the ceramic head is that is has come into contact with the hip cup, hip prosthesis or instruments.No other issues have been identified with this product.A review of the complaints database shows that we have received 23 reported events for revision for the same item number 650-1057 prior to the reported event.Risk assessment: the severity associated with the above line is 3 (moderate) this gives a severity score of s-3 (moderate) as per rmr.The actual severity score is 3 (moderate) in line with the risk table occurrence rate assessment: december 2017 to december 2020: 57890 items sold.Number of similar complaints identified: 24 (including initiating complaint).Occurrence ratio: 1:2412.Risk score: severity 3 x occurrence 3 (occasional) = 9 (moderate risk).Although the risk is moderate based on the risk file, it is calculated using the limited information provided therefore as the product is dimensionally conforming is likely to be a lower risk.The severity of the reported event and calculated occurrence for similar complaints are in line with the risk file the overall score is moderate risk.No corrective or preventive action is considered necessary at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Common Device Name: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11035800
• Report Number: 3002806535-2020-00551
• Device Sequence Number: 19506131
• Product Code: LPH
• UDI-Device Identifier: 00887868271397
• UDI-Public: 00887868271397
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082996
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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 Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 2066562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 03/24/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention