MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA HEAD, 36MM +3MM NECK, TYPE 1 TAPER; PROSTHESIS, HIP, SEMI-CONSTRAINED

Model Number	650-0662
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical device: acetabular shell g7 3 hole, pps; catalog#010000664; lot#7167132, trilogy self-tapping bone screw; catalog#63759079; lot#63759079, acetabular g7 liner, longevity; catalog#20103606 ; lot#65255998, femoral stem echo bi-metric full proximal profile, lateralized; catalog#192111; lot#501010.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient was bending and twisting and felt a pop and increased pain on left hip approximately 1,5 month after initial left hip procedure.Anterior dislocation was confirmed; patient underwent a reduction under anesthesia.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed, later the patient was bending and twisting and felt a sudden pop with pain.Attempts at closed reductions were unsuccessful in the er, so the hip was reduced under anesthesia.No fractures noted.It was reported the patient was bending and twisting and felt a sudden pop.However, a root cause cannot be identified.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
No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA HEAD, 36MM +3MM NECK, TYPE 1 TAPER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• 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: 14631121
• Report Number: 3002806535-2022-00268
• Device Sequence Number: 17050453
• Product Code: LZO
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)311028(10)3090731
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 650-0662
• Device Catalogue Number: 650-0662
• Device Lot Number: 3090731
• Was Device Available for Evaluation?: No
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 86 KG