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

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported from an experienced orthopedic surgeon that he had a broken ceramic head some time ago during application to cone taperloc 11/13.Normal procedure, allofit/taperloc total hip replacement.No clinical signs, symptoms or conditions reported.No delay of the surgery reported.

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 complaints product evaluation engineer for investigation.The event reports that the ceramic head fractured.This occurred during surgery.No further information has been provided.The complaint has been confirmed following review of the returned implant, which confirmed the ceramic head is fractured.A review of the device history records for the packaging process and a review of the cof c for the implant did not identify any discrepancies that would have contributed to the reported event.This device is used for treatment.The fractured femoral head had a type 1 taper.The complaint description mentions that the head was applied to cone taperloc 11/13.However, taperloc stems come only in type 1 or 12/14 tapers.Therefore, it is unclear whether a taperloc stem with a 12/14 or type 1 taper was used.However, this cannot be confirmed without surgical notes and information about the other implanted components.Given the clear references to a taperloc stem having been used, it appears unlikely that a femoral stem with an 11/13 taper from another manufacturer was used.The likely condition of the device when it left zimmer biomet is conforming to specification.Visual examination of the fractured component suggests that suboptimal seating of the femoral head on the stem taper during impaction may have contributed to the adverse event.However, it is not possible to determine the cause without surgical notes and additional information being provided.These have been requested, but were not available.No corrective action has been initiated as a definitive root cause has not been established, and the severity of the reported event is in line with the risk file, and no issues with the occurrence rate of similar reported events are in line with the relevant risk file.Risk assessment: a) severity assessment: this incident has a severity score of 2, potential for extended surgery time while a new implant was located.The actual severity score is in line with the risk file.B) occurrence assessment: jan 2018 to feb 2021: (b)(4) items sold.Number of similar complaints identified: (b)(4).C) occurrence ratio: (b)(4).This gives an occurrence score of 3.As the root cause of the events can not be determined, the risk score can not be compared to a single line.D) risk assessment summary: the reported event is covered by risk management report, which documents the estimated residual risk associated with the reported event.The severity of the reported event is in line with the risk file.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 Description

It was reported by the surgeon that he had a broken ceramic head some time ago during application to cone taperloc 11/13.The incident happened during a normal procedure, allofit/taperloc total hip replacement.

• Brand Name: DELTA CER FEM HD 32/-3MM T1
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10859462
• MDR Text Key: 216901529
• Report Number: 3002806535-2020-00489
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1163
• Device Lot Number: 2020031492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1