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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651); Unequal Limb Length (4534)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: tloc 133 mp sp t1 pps ho 7x99 item#51-109070 lot#3652988.G7 pps ltd acet shell 52e item#010000663 lot#7061616.36mm i.D.Size e neutral liner item#30103605 lot#65256574.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 underwent a revision procedure of the right hip approximately one month post implantation due to subsidence of the femoral stem after limb length discrepancy was noted.During revision, a crack in the upper femoral shaft and the greater trochanter developed.These were repaired and the final components were replaced without further complication.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: DELTA CERAMIC FEM HD 36/0MM
• Common Device Name: HIP PROTHESIS
• 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: 14641533
• Report Number: 3002806535-2022-00271
• Device Sequence Number: 5720863
• Product Code: LZO
• UDI-Device Identifier: 00887868271175
• UDI-Public: (01)00887868271175(17)311116(10)3095543
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0661
• Device Lot Number: 3095543
• 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: 05/14/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 66 KG