MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM STD NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	12-115121
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left hip arthroplasty approximately two years ago.Subsequently, the patient is being considered for a revision due to dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10 - associated products: g7 vit e neutral lnr 36mm d; item# 30103604; lot# 64780117.G7 pps ltd acet shell 50d; item# 010000662; lot# 6886707.G7 screw 6.5mm x 30mm; item# 010000999; lot# 6825839.Echo por fem red lat nc 10x130; item# 192510; lot# 827220.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.All of the images demonstrate an anatomically aligned total hip arthroplasty without dislocation.The acetabular cup appears to demonstrate increased anterior inclination in which the posterior rim of the cup is set at a level which is inferior to the anterior rim of the cup.This could potentially predispose the femoral head component to displaced/dislocated anterior to the acetabular cup.The hardware and bones appear intact without fracture with no periprosthetic lucency detected.The right total hip arthroplasty appears grossly unremarkable.Overall fit appears normal.The requested angle measurements can not be performed.No signs of loosening, wear, radiolucency, or other contributing factors.No dislocation at the time of imaging.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
No further event information available at the time of this report.

• Brand Name: CER BIOLOXD MOD HD 36MM STD NK
• 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: 17486858
• Report Number: 3002806535-2023-00271
• Device Sequence Number: 12574363
• Product Code: LZO
• UDI-Device Identifier: 00887868248481
• UDI-Public: (01)00887868248481(17)290507(10)2986081
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 10/06/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 12-115121
• Device Lot Number: 2986081
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 09/26/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/04/2023; 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female