MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER CONE PROSTHESIS, 125, UNCEMENTED, 21, TAPER 12/14; WAGNER CONE PROSTHESIS SYSTEM

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical products: bone screw self-tapping 6.5 mm dia.50 mm length; catalog#: 00-62-5006-550; lot#: 64143387; bone screw self-tapping 6.5 mm dia.35 mm length; catalog#: 00-6250-065-35; lot#: j6829869; biomet bc r 1x40 us; catalog#: 110035368; lot#: 027caa1602; biomet bc r 1x40 us; catalog#: 110035368; lot#: f2701z12ba.Therapy date: (b)(6) 2021.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 the right side and underwent a revision surgery due to infection.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.D10: medical products: bone screw self-tapping 6.5 mm dia.50 mm length; catalog#: 00-62-5006-550; lot#: 64143387; bone screw self-tapping 6.5 mm dia.35 mm length; catalog#: 00-6250-065-35; lot#: j6829869; biomet bc r 1x40 us; catalog#: 110035368; lot#: 027caa1602; biomet bc r 1x40 us; catalog#: 110035368; lot#: f2701z12ba.Therapy date: (b)(6) 2021.Additional information which was received on jun 08, 2021.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent a revision surgery due to infection.Both cement and wagner cone stem were utilized as a temporary spacer while clearing the infection.
Additional Manufacturer Narrative
Investigation results were made available.Review of event description: it was reported that the patient was implanted on the right side with a temporary wagner cone prosthesis on dec 29, 2020 due to infection and underwent revision to implant the final implants on apr 04, 2021 after the patient cleared off his infection.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: the product was disposed after removal on apr 04, 2021.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Sterilization certificate: the gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot number has been reviewed and was found to be according to specifications.Conclusion: it was reported that the patient was implanted on the right side with a temporary wagner cone prosthesis on dec 29, 2020 due to infection and underwent revision to implant the final implants on apr 04, 2021 after the patient cleared off his infection.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).The sterilization certification was 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.Neither medical records nor the products were provided.Since it was reported that the wagner cone prosthesis was used only temporarily during treatment of the infection, no product-related problem is apparent.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 CONE PROSTHESIS, 125, UNCEMENTED, 21, TAPER 12/14
• Common Device Name: WAGNER CONE PROSTHESIS SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11912969
• Report Number: 0009613350-2021-00249
• Device Sequence Number: 13683902
• Product Code: LZO
• UDI-Device Identifier: 00889024485099
• UDI-Public: 00889024485099
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2021

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 01.00561.221
• Device Lot Number: 3023674
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 08/19/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/21/2021; 08/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention