MAUDE Adverse Event Report: Zimmer Manufacturing B.V. BONE SCR 6.5X50 SELF-TAP; Prosthesis, Hip

Catalog Number	00625006550
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction

• 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 ; +1(574)526-0384
• MDR Report Key: 50882156
• Report Number: 0002648920-2026-00175
• Device Sequence Number: 16119081
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 67084885
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown