MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED,15/190, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: biolox delta, ceramic femoral head, xl, 36/+7, taper 12/14; catalog#: 00-8775-036-04; lot#: 3059358b2.Adler ortho head 36 mm; catalog#: 0813603; lot#: t36471ab.Adler ortho insert 54/56x36mm 3-b; catalog#: 0753352; lot#: t32159aa.Adler ortho screw 6.5 mm; catalog#: 0601030; lot#: t17518aa.Adler ortho screw 6.5 mm; catalog#: 0601030; lot#: t25940aa.Report source ¿ foreign: (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00314.
Event or Problem Description
It was reported that: the patient underwent a revision surgery approximately 1 month after the implantation due to periprosthetic instability and bone fracture.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product was not returned for investigation.Therefore, visual and dimensional evaluation could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation confirmed with increased lateral inclination noted as a contributing factor.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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 corrected information.Further information was received which reported that the patient was revised approximately 1 month postop due to dislocation.A pre-revision radiograph was provided and reviewed by a health care professional.The femoral component is dislocated superolaterally with respect to the acetabular cup.The acetabular cup demonstrates increased lateral inclination, a finding which can predispose to dislocation.Hardware appears intact.No periprosthetic lucencies.Bones appear intact without fracture or osteopenia.No signs of loosening, wear, radiolucency, or contributing factors.This corrected information does not change the outcome of the investigation previously reported.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Further information was received which reported that the patient experienced a left hip dislocation immediately after surgery.Revision surgery was performed approximately 1 month postop.

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED,15/190, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14539619
• Report Number: 0009613350-2022-00313
• Device Sequence Number: 4956858
• Product Code: JDI
• UDI-Device Identifier: 00889024593466
• UDI-Public: (01)00889024593466(17)260816(10)3080465
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K871347
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2022

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 Expiration Date: 08/16/2026
• Device Model Number: N/A
• Device Catalogue Number: 01.00101.915
• Device Lot Number: 3080465
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 08/05/2022; 08/05/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 07/28/2022; 08/16/2022; 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 72 KG