MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X15 SELF-TAP; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# p0463046 lot# 0001611795 avan cmntd shell ss 46mm.Cat# ep-200146 lot# 694590 act artic e1 hip brg 28x40mm.Cat# 87-5954 lot# 9269605 s-rom femoral head.G2: foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2023 -00179, 0001822565 -2023 -02058, 0001822565 -2023 -02059, 0002648920 -2023 -00174, 0001822565 -2023 -02060, and 0001822565 -2023 -02061.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient underwent a revision approximately 1 year later due to bone loss.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.It was identified some of the screws used are not compatible with the shell, however it is unknown if it caused or contributed to the reported event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BONE SCR 6.5X15 SELF-TAP
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17471383
• Report Number: 0002648920-2023-00178
• Device Sequence Number: 11440865
• Product Code: LPH
• UDI-Device Identifier: 00889024119796
• UDI-Public: (01)00889024119796(17)280630(10)64093861
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K921308
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006515
• Device Lot Number: 64093861
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 80 KG