MAUDE Adverse Event Report: Zimmer GmbH WAGNER SL REVISION DIA16/190; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer

Catalog Number	01.00101.916
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from a clinical study that a patient underwent a right hip stage i revision arthroplasty with final implants used as a spacer for infection.Subsequently, a stage ii revision arthroplasty was performed; during which, the gross aseptic loosening was noted in the cup and stem.All components were revised without complication.The patient entered the current study at the stage ii revision with no further concerns or complications reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: item: unk - unk cup - lot: unk.Item: 00625006570 - bone screw self-tapping 6.5 mm dia.70 mm length - lot: j7247488.Item: 30253607 - liner constrained +5 mm offset 36 mm i.D.Size g - lot: 67052073.Item: 802403601 - constrained head 12/14 taper 36 mm diameter -6 mm - lot: 3256940.Item: unk - biomet cement - lot: unk.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 3500a will be submitted.

• Brand Name: WAGNER SL REVISION DIA16/190
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer
• Manufacturer (Section D): Zimmer GmbH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): Zimmer GmbH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50453557
• Report Number: 0009613350-2026-00444
• Device Sequence Number: 9838069
• Product Code: LZO
• UDI-Device Identifier: 00889024593473
• UDI-Public: (01)00889024593473(17)270120(10)3098024
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: Lay User/Patient
• Device Catalogue Number: 01.00101.916
• Device Lot Number: 3098024
• 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: 08/10/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11 narrative.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 193 LB
• Patient Race: White