MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, 17/225, TAPER 12/14; WAGNER SL REVISION STEM LATERAL

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on an unknown side and underwent a revision surgery due to periprosthetic fracture and implant fracture.
Additional Manufacturer Narrative
Investigation results were made available.Review of event description: it was reported that the patient received a wagner sl revision stem on an unknown date and was revised on an unknown date due to periprosthetic fracture.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Incident report from (b)(6) from (b)(6) 2021 (report number (b)(6)): incident date: (b)(6) 2021 implantation date: (b)(6) 2021 (please note that the correctness of this date could not be verified.) reason for implantation: replacement of previously implanted stem with a revision stem due to periprosthetic fracture.Procedure: revision of prosthetic stem due to periprosthetic fracture and application of cerclage wires.Duration of intervention: 2h 55min time of stay in hospital: 15 days time of persistence of the device: 3 years and 10 months description of the incident: periprosthetic fracture product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient received a wagner sl revision stem on an unknown date and was revised on an unknown date due to periprosthetic fracture.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Neither x-rays, operative notes, office visit notes, nor the stem or photos of the stem were received.Patient factors that may have affected the performance of the stem such as bone quality, activity level, type of activity, and relevant medical history are unknown.Therefore, due to the lack of medical records, the reported periprosthetic fracture could not be confirmed.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.Investigation results are now available.

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED, 17/225, TAPER 12/14
• Common Device Name: WAGNER SL REVISION STEM LATERAL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11705522
• Report Number: 0009613350-2021-00182
• Device Sequence Number: 4330979
• Product Code: LZO
• UDI-Device Identifier: 00889024485228
• UDI-Public: 00889024485228
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K043356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.00102.217
• Device Lot Number: 2877204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR