MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/+3MM; BIOLOX DELTA CER FEM HD LG DIA

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Medical product: tprlc 133 type1 bm so 10.0, catalogue number: 51-113100, lot number: 7052810.Medical product: g7 neutral e1 liner 36mm d, catalogue number: 010000856, lot number: 7057314.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 went to have her hip x-rays done post-op.As she was getting into position for her x-ray she felt a 'crunch' and then excruciating pain.The x-ray shows the ceramic head broken into 3 pieces.Surgery is needed to remove broken and affected implants.New implants put in.Patient outcome: revision.
Event or Problem Description
It was reported, that: the patient went to have her hip x-rays done post-op.As she was getting into position for her x-ray she felt a 'crunch' and then excruciating pain.Xray shows the ceramic head broken into 3 pieces.Surgery is needed to remove broken and affected implants.New implants were put in.Patient outcome: revision.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: a biolox delta ceramic head, a g7 neutral e1 liner and a taperloc stem were received for analysis after the head fractured after approximately 1 day in service when the patient was moving into position to have her post-operative x-rays taken.Visual examination of the fractured head shows metal transfer marks within the taper, as well as numerous metal transfer marks on all surfaces, likely from contact with the metal stem, acetabular shell and/or from contact with instruments during removal.The received e1 liner presented severe wear and damage from the screw technique used to extract it and from contact with sharp ceramic fragments and/or the edge of the femoral stem taper and/or by a sharp instrument during revision.Evaluation of the provided radiographs showed that the acetabular shell was positioned at about 38.5° inclination, just below the recommended 40°.The received taperloc stem presented damage to the taper and the neck, likely caused by instruments during revision and possibly also by contact with ceramic fragments and/or with the acetabular shell after the biolox delta head fracture.The manufacturing history records (mhrs) of the biolox delta head, g7 neutral e1 liner and taperloc stem have been checked and verified that the parts were manufactured and sterilised in accordance with the applicable specifications.This device is used for treatment.A compatibility check confirms there are no issues.A complaint history search identified additional no similar complaints about the reported item and no additional complaints about the reported item and lot combination.The root cause of the ceramic head fracture could not be determined in this instance.However, the patient¿s bmi, acetabular dysplasia and her movement when getting into position for the x-rays, as well as a sub-optimal component selection during primary surgery may have contributed to the ceramic head fracture.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to the reported event.No corrective or preventive action is required at this time.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DELTA CERAMIC FEM HD 36/+3MM
• Common Device Name: BIOLOX DELTA CER FEM HD LG DIA
• 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: 13665735
• Report Number: 3002806535-2022-00090
• Device Sequence Number: 11927133
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: 00887868271182
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 650-0662
• Device Lot Number: 3063441
• Was Device Available for Evaluation?: Yes
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• 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: SEEH10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 72 KG