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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 110010265 - g7 osseoti multihole 54mm f - 64966784.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 will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01154, 0001822565-2024-01155, and 0001822565-2024-01156.
Event or Problem Description
It was reported that the patient underwent a hip revision approximately 14 months post implantation due to a loose acetabular component.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 - concomitant devices - trilogy self-tapping bone screw 6.5mm x 20mm catalog #: 00625006520 lot #: j7520786, trilogy self-tapping bone screw 6.5mm x 30mm catalog #: 00625006530 lot #: j7583503, trilogy self-tapping bone screw 6.5mm x 30mm catalog #: 00625006530 lot #: j7583512, trilogy self-tapping bone screw 6.5mm x 20mm catalog #: 00625006520 lot #: j7418038, g7 osseoti multihole 54mm catalog #: 110010265 lot #: 64966784, vivacit-e dm bearing 28mm x 44mm catalog #: 110031012 lot #: 66178860, g7 dual mobility liner 44mm catalog #: 110024464 lot #: 66242527, biolox delta femoral head 28mm +0mm catalog #: 00877502802 lot #: 3111679.Radiographs provided confirmed abnormal vertically-oriented position of the acetabular cup consistent with the patient's history of acetabular component loosening.No dislocation was noted and the femoral component was intact.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.
Event or Problem Description
No further event information available at the time of this report.

• 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: 19041918
• Report Number: 0002648920-2024-00097
• Device Sequence Number: 12882284
• Product Code: LPH
• UDI-Device Identifier: 00889024119796
• UDI-Public: (01)00889024119796(17)260930(10)63486202
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00625006515
• Device Lot Number: 63486202
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2016
• 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 Sex: Female
• Patient Weight: 120 KG