MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/0MM T1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Subluxation (4525); Joint Laxity (4526); Joint Impingement (4834)
Date of Event	09/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: g7 osseoti 3 hole shell 48mm c; (b)(4); lot#65571969, trilogy bone scr 6.5x35; (b)(4); lot#j7448916, trilogy bone scr 6.5x20; (b)(4); lot#65840540, g7 vit e neutral lnr 32mm c; (b)(4); lot#64874029, tprlc 133 fp type1 pps so 8.0; (b)(4); lot#6137651, pr std st/oss lh cp/ve ln cer; (b)(4); lot#unknown.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 as initial right total hip arthroplasty.Subsequently revised due to subluxation and instability.During the revision posterior impingement, acetabular component not in a functional position, and joint laxity.The stem was well fixed and remained implanted.The acetabular shell, liner, and head were exchanged without complication.Approximately 85 days post-implantation.Attempts have been made and all additional information received has been included in this report.
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.The device is used for treatment.Radiographs were provided and reviewed by a radiologist.Right hip arthroplasty with anatomic alignment and no acute abnormality.There is suspected excessive cup anteversion as noted which may be associated with recurrent subluxation and dislocation.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.

• Brand Name: DELTA CER FEM HD 32/0MM T1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 17860117
• Report Number: 3002806535-2023-00332
• Device Sequence Number: 20315737
• Product Code: LZO
• UDI-Device Identifier: 00887868271564
• UDI-Public: (01)00887868271564(17)310519(10)3069883
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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 Model Number: N/A
• Device Catalogue Number: 650-1162
• Device Lot Number: 3069883
• 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: 09/09/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 65 KG