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: the patient underwent a double-action, total hip replacement surgery at (b)(6) hospital on (b)(6) 2021.Post-operative examination revealed that the prosthesis was dislocated internally and the femoral head was dislocated from the liner.This was followed by a revision surgery on (b)(6) 2021 to replace the femoral head and the liner, then it was repositioned.Patient involvement - revision - prolonged surgery.
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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to make a correction.The following sections were updated: b4, b5, g3, g7, h1, h2, h10.Upon reassessment of the reported event, it was determined that the event had been reported twice.(b)(4) is a duplicate of (b)(4).This medwatch will be voided.This event will be reported by medwatch facility (b)(4).
Event or Problem Description
It was reported : (b)(6) hospital performed a double-action total hip replacement surgery on the patient on (b)(6) 2021.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) 2021 to replace the femoral head and liner and then repositioned.

• 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: 13001305
• Report Number: 3002806535-2021-00527
• Device Sequence Number: 4647050
• 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): 12/20/2021

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: 650-1159
• 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: 12/16/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown