MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/+3MM T1; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report: unique identifier (udi) number: (b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during primary hip surgery, the ceramic head fractured after repositioning.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the product evaluation complaints engineer for investigation.The event reports that the ceramic head fractured during surgery after repositioning.The complaint has been confirmed following review of the returned implant, which confirmed the ceramic head has fractured.The fractured ceramic head was returned in three major fragments.Small gaps were present between the fragments.We have received information which confirms that no fragments remain in vivo.The manufacturing history records (mhrs) and the certificate of conformance for the biolox delta head have been checked and verify that the part was manufactured and sterilised in accordance with the applicable specifications.A complaint history review identified no further complaints for the same item/lot combination.A complaint history review identified 1 additional complaint for implant fracture (2 complaints in total).As the root cause of this event and additional similar events for implant fracture identified has not been determined, it is not possible to group the events and compare them to a single line in the risk file, as multiple lines could be applicable.Therefore, the occurrence score in the risk file remains acceptable following review of reported events.This device is used for treatment.The likely condition of the device when it left zimmer biomet is conforming to specification.The likely cause of the reported event cannot be determined with the information available, however, given the uneven and irregular transfer marks on the taper surface of the ceramic head then sub-optimal component alignment during assembly could be a contributing factor.No corrective action required as no design or manufacturing deficiency has been identified and the severity of the reported event is in line with the risk file.The occurrence rate for all similar reported event also remains applicable.Risk assessment: the risk file has multiple lines which cover a hazard of implant fracture.These lines have a severity score of 4 (results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention) and an occurrence rate of 1 (remote - very unlikely to occur (less than 1 in 10,000)).Severity assessment: the event occurred during surgery, no further harm was reported.This gives a score of 2 (temporary or reversible impairment (without medical intervention) / transient, minor impairment or complaints) which does not exceed the severity score on the relevant line in the risk management file.Occurrence assessment : the occurrence rate has been calculated using sales and complaint for a time period of 3 calendar years before the notification date to current date for the item number.Notification date: sep 2020.Sales data time period: jan 2017 to dec 2020.Number of sales: (b)(4).Complaint data time period: 01 jan 2017 to 25 jan 2021 (current date) number of complaints: (b)(4).Complaint ratio: (b)(4).Occurrence score: (b)(4).As the root cause of this event and the additional similar event identified has not been determined, it is not possible to group the events and compare them to a single line in the risk file, as multiple lines could be applicable.Therefore, the occurrence score in the risk file remains acceptable following review of reported events.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.
Event or Problem Description
It was reported that during primary hip surgery which was performed on (b)(6) 2020, the ceramic head fractured after repositioning.

• Brand Name: DELTA CER FEM HD 32/+3MM T1
• 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: 10527793
• Report Number: 3002806535-2020-00415
• Device Sequence Number: 3055497
• Product Code: LPH
• UDI-Device Identifier: 00887868271557
• UDI-Public: 00887868271557
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 650-1161
• Device Lot Number: 2020021238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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