MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/0MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign- argentina.Item name: g7 screw 6.5mm x 25mm; item# 010000998; lot# 6861266; item name: g7 pps ltd acet shell 58g; item# 010000666; lot# 6883595; g7 neutral arcomxl lnr 36mm g; item# 010000742; lot# 6628991; taperloc por lat fmrl 12.5x145; item# 11-103206; lot# 939270; investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient was revised approximately 9 months post implantation due to femoral head implant fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records/radiographs were provided and reviewed by a health care professional which confirmed the reported event.Radiograph review observed that the implant fit was maintained without evidence of loosening.Regarding alignment, there is mild subluxation of the fractured femoral head implant without dislocation.Bone quality appears normal.No other implant or anatomical concerns are identified.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: DELTA CERAMIC FEM HD 36/0MM
• Common Device Name: PROSTHESIS, HIP
• 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: 15158811
• Report Number: 3002806535-2022-00342
• Device Sequence Number: 12128672
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: (01)00887868271175(17)310315(10)3062817
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K200959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: N/A
• Device Catalogue Number: 650-0661
• Device Lot Number: 3062817
• 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: 07/05/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2021
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 102 KG