MAUDE Adverse Event Report: ZIMMER GMBH WAGN CONE PROSTHESIS 135/17; PROSTHESIS, HIP

Catalog Number	0100561317
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Scar Tissue (2060); Synovitis (2094); Swelling/ Edema (4577); Bursitis (4832); Medical device site infection (4845); Aseptic loosening (4883); Septic loosening (4884)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 110010243, g7 osseoti 3 hole shell 50mm d, lot#: 65862844.Item#: 00625006520, trilogy bone scr 6.5x20, lot#: j7488887.Item#: 00625006525, trilogy bone scr 6.5x20, lot#: j7526159.Item#: 30103604, 36mm i.D.Size d neutral liner, lot#: 66179347.Item#: 00877503603, trilogy bone scr 6.5x20, lot#: 3122141.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip replacement.Subsequently, patient is being considered for a revision due to stem loosening.Hip aspiration cultures showed no growth which correlates with bone scan results that indicate loosening with infection unlikely.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a6, b4, b5, b7, d6b, d10, e1, g3, g6, h2, h6, h11.D10: item # 00877503603, biolox delta hd 12/14 36x+3.5, lot # 3156929 item # 110010243, g7 osseoti 3 hole shell 50mm d, lot # 65862844 item # 00625006520, trilogy bone scr 6.5x20, lot # j7488887 item # 00625006525, trilogy bone scr 6.5x20, lot # j7526159 item # 30103604, 36mm i.D.Size d neutral liner, lot # 66179347.Item # 00877503603, trilogy bone scr 6.5x20, lot # 3122141.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
It was reported that the patient underwent an initial hip replacement.After one year and eleven months hip aspiration was positive for streptococcus mitis.Subsequently, approximately two years post implantation, revision surgery was performed due to stem loosening and infection.All components were replaced with cement spacers without complications.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.The following sections were updated: b2, b4, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories identified additional similar complaints for the reported items and the part and lot combinations.Medical records were provided for the revision surgery and was reviewed by a health care professional who reported there was evidence of infection, including hypertrophic scarring, synovitis the stem well fixed and required an osteotomy for explanation and was repaired with cerclage cables.The acetabular explanted without difficulty, cement spacers placed.No complications were reported.A definitive root cause could not be determined.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.Furthermore review of the revision notes confirmed that the stem was not loose and was well fixed.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.

• Brand Name: WAGN CONE PROSTHESIS 135/17
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• 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 ; 5745260384
• MDR Report Key: 23350409
• Report Number: 0009613350-2025-00781
• Device Sequence Number: 7956827
• Product Code: LZO
• UDI-Device Identifier: 00889024593251
• UDI-Public: (01)00889024593251(17)270810(10)3122141
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 0100561317
• Device Lot Number: 3122141
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 02/24/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/08/2025; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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; Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White