MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER CONE PROSTHESIS, 135, UNCEMENTED, 19, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: g7 osseoti 3 hole shell 50mm d item# 110010243 lot# 65346043; g7 vit e neutral lnr 36mm d item# 30103604 lot# 65338039; bone screw self-tapping 6.5 mm dia.30 mm length item# 00625006530 lot# j7263653; bone screw self-tapping 6.5 mm dia.30 mm length item# 00625006530 lot# j7263667; biolox delta, ceramic femoral head, s, 36/-3.5, taper 12/14 item# 00877503601 lot# 3111466; cable cerclage cable with crimp 1.8 mm dia.635 mm length item# 00223200418 lot# 64927345.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the femur fractured while implanting cone stem.Cables were used to fix the fracture intraoperatively.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the concerned product is not zimmer switzerland manufacturing gmbh design control.The event will be further reported by zimmer inc.Given this information, this medwatch will be voided.
Event or Problem Description
The device previously reported on this medwatch is not related to the reported event.

• Brand Name: WAGNER CONE PROSTHESIS, 135, UNCEMENTED, 19, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED
• 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: 15256592
• Report Number: 0009613350-2022-00425
• Device Sequence Number: 20501409
• Product Code: LZO
• UDI-Device Identifier: 00889024480834
• UDI-Public: (01)00889024480834(17)261125(10)3095394
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/08/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00561.319
• Device Lot Number: 3095394
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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 Sex: Unknown