MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURER GMBH WAGNER CONE PROSTHESIS 125, UNCEMENTED, 16, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED

Catalog Number	01.00561.216
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported there was an issue related to femoral stem and an unknown medical procedure.Attempts have been made and no further information has been provided yet.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: unknown wagner trial stem; product identification unknown.Therapy date: unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).Upon reassessment of the reported event, it was determined to be a duplicate of mfr report number 0009613350-2022-00518.Hence this report should be voided.Given the above information, this medwatch will be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined to be a duplicate of mfr report number 0009613350-2022-00518.Hence this report should be voided.

• Brand Name: WAGNER CONE PROSTHESIS 125, UNCEMENTED, 16, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURER 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: 15637797
• Report Number: 0009613350-2022-00551
• Device Sequence Number: 5677470
• Product Code: LZO
• UDI-Device Identifier: 00889024593183
• UDI-Public: (01)00889024593183(17)241130(10)3013909
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 11/30/2024
• Device Catalogue Number: 01.00561.216
• Device Lot Number: 3013909
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female