MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER CONE PROSTHESIS, 135, UNCEMENTED¸ 14, TAPER 12/14; WAGNER CONE PROSTHESIS SYSTEM

Model Number	N/A
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical product: femoral head sterile product do not resterilize 12/14 taper; catalog#: 00-8018-022-30; lot#: 63452825; unk-hip-unk-liner; catalog#: unknown; lot#: unknown; femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 9 100 mm stem length cementless; catalog#: 00-7864-009-00; lot#: 63456639.Therapy date: (b)(6) 2020.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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
It was reported that there was a revision due to dislocation and loosening.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g3, g6, h10.While checking the documents it was found that the winterthur wagner stem ref# 01.00561.314, lot# 2936141 was implanted during the revision surgery performed on (b)(6) 2020.The stem implanted on (b)(6) 2020 that was involved in the reported event is a press-fit femoral stem from zimmer biomet warsaw, already covered in split-case (b)(4) and reported with 0001822565-2021-03565.Please invalidate the case from your system.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
See h10.

• Brand Name: WAGNER CONE PROSTHESIS, 135, UNCEMENTED¸ 14, 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
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 12876697
• Report Number: 0009613350-2021-00617
• Device Sequence Number: 11889529
• Product Code: LZO
• UDI-Device Identifier: 00889024480797
• UDI-Public: 00889024480797
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 12/15/2021

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00561.314
• Device Lot Number: 2936141
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown