MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X50 SELF-TAP; PROSTHESIS, HIP

Catalog Number	00625006550
Medical Device Problem Codes	Positioning Failure (1158); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: 54mm o.D.Size jj porous uncemented with cluster holes shell use with jj liners.Item: 00875705401.Lot: 66794013.G2: foreign ¿ china.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that the acetabular screw could not be fully inserted during implantation.Repeated tapping attempts still failed to secure it.Upon removal, thread scratches were observed, along with a double thread at the tip.Replacing it with a screw of the same specification and batch number resulted in successful implantation.30 mins delay.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
It was confirmed that no further information could be provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d9; g3; h2; h3; h6; h10.Visual examination of the returned product identified the peak on approximately half of the screw threads is rolled over and fractured.The fractured portion is retained on the device.There are scratches around the base of the head of the screw.No other damage was noted during visual evaluation.Where measured, the device was conforming.The cup was not returned.Review of the device history records identified no deviations or anomalies during manufacturing.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 trends.

• Brand Name: BONE SCR 6.5X50 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: 24604086
• Report Number: 0002648920-2026-00039
• Device Sequence Number: 13349888
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)340209(10)66540081
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00625006550
• Device Lot Number: 66540081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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 H11
• Patient Sex: Unknown