MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Erosion (1750); Osteolysis (2377)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent left hip revision approximately 1-year post implantation due to significant bone loss resulting in loosening of the cup.No additional information on the reported event.
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical products: 00625006520- bone screw self-tapping 6.5 mm dia.20 mm length- 64615051; 00625006520- bone screw self-tapping 6.5 mm dia.20 mm length- j6963834; 00625006540- bone screw self-tapping 6.5 mm dia.40 mm length- j6923630; 00625006525- bone scr 6.5x25 self-tap- j6925770; 110010267- g7 osseoti multihole 58mm g- 7121443; 31-323240- 3.2mmx40mm rnglc+ acet drl bit- 614350; ep-200152- act artic e1 hip brg 28x46mm- 735920; 110024465- g7 dual mobility liner 46mm g- 492650.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2022 - 00235; 0002648920 - 2022 - 00236; 0002648920 - 2022 - 00237; 0002648920 - 2022 - 00238.Customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 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 related to the reported event.A definitive root cause cannot be determined.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 additional information on the reported event.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH
• 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: 15877506
• Report Number: 0002648920-2022-00234
• Device Sequence Number: 12134138
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)271031(10)63794457
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/23/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006550
• Device Lot Number: 63794457
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• 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: NI
• 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