MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Muscle/Tendon Damage (4532)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent revision due to retear of the gluteus medius, dislocation, and disassociation of the dual mobility components.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: associated products: item reference: 650-1068, item name: cer option type 1 tpr sleve +6, item lot: 3066235.Item reference: 110024464, item name: g7 dual mobility liner 44mm f, item lot: 725530.Item reference: 110031000, item name: longevity dm bearing 28x44mm, item lot: 65509335.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, h10.Visual examination of the returned product identified heavy scuffing (metal transfer marks) and scratching on the outer radius.Similar scratching was found inside the taper.No other defects were observed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records & radiographs were provided and reviewed by a health care professional.The head was noted to be located within the joint but the poly portion of the dual mobility was just posterior and superior to the acetabulum.All of the sutures from the previous gluteus medius repair were torn.Contributing factors of event: previous gluteus medius avulsion repair and re-tear.With the available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Attempts have been made and no further information has been provided.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 16687538
• Report Number: 3002806535-2023-00105
• Device Sequence Number: 5921002
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: (01)00887868271373(17)320519(10)3114760
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 05/24/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 3114760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female