MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 28/-3MM T1; BIOLOX DELTA CERAMIC FEM HD

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: (b)(6) hospital performed a double-action total hip replacement surgery on the patient on 11/30.Postoperative examination revealed that the prosthesis was dislocated internally and the femoral head was dislocated from the liner, followed by another incisional surgery on 12/1 to replace the femoral head and liner and then repositioned.Patient involvement - revision.
Additional Manufacturer Narrative
(b)(4).Initial report.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.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: (b)(6) hospital of (b)(6) university performed a double-action total hip replacement surgery on the patient on (b)(6).Postoperative examination revealed that the prosthesis was dislocated internally and the femoral head was dislocated from the liner, followed by another incisional surgery on (b)(6) to replace the femoral head and liner and then repositioned.Patient involvement: revision.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: the head and liner are compatible with each other.The compatibility of whole construct cannot be performed as the details of stem and shell are not provided.A visual inspection of the delta ceramic femoral head shows dark metallic marks and lines all over the spherical diameter most likely caused by contact with a metallic object (shell) as well as in the internal taper most likely caused by the assembly onto to hip stem.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.This device is used for treatment.It has been confirmed that the instrument/implant is not within the scope or subject of any field actions or recalls which could be attributed to reported event.A dimensional inspection was carried out and the delta ceramic femoral head is conforming to specification.The definitive root cause of this event cannot be determined with the available information.A review of the complaints database shows that we have received 2 reported events for revision due to dislocation for the same item number 650-1159 prior to the reported event.Corrective or preventative action not required.The root cause of the reported event cannot be determined with the information provided.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.

• Brand Name: DELTA CER FEM HD 28/-3MM T1
• Common Device Name: BIOLOX DELTA CERAMIC FEM HD
• 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: 12966219
• Report Number: 3002806535-2021-00521
• Device Sequence Number: 11905438
• Product Code: LZO
• UDI-Device Identifier: 00887868271533
• UDI-Public: 00887868271533
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/31/2022

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: 650-1159
• Device Lot Number: 3062094
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Unknown