MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH WAGNER SL REVISION HIP STEM, UNCEMENTED, 15/225, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent an initial hip arthroplasty.Subsequently, a revision procedure due to implant fracture was performed.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: zimmer, biolox delta head 28 l item# 00-8775-028-03 lot# 2777817l14.Zimmer, trofix plate 150mm item# 02.02270.150 lot# unknown.Arthrex, fibretape cerclages item# unknown lot# unknown.Report source: foreign - germany.Investigation of this incident is currently ongoing.A followup/ final report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified ductile fracture of stem across distal.In addition, there is evidence of surface damage and significant scratches, however this could have been caused during explant.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic fracture of the right proximal femur with subsequent revision and anatomic alignment.Later femoral and femoral implant fracture with varus angulation.Subsequent revision with anatomic alignment.Bone quality appears osteopenic which could contribute to the fracture.Arthroplasty alignment is maintained on all images.There is femoral implant loosening secondary to the implant shaft and adjacent femur fractures.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified ductile fracture of stem across distal.In addition, there is evidence of surface damage and significant scratches, however this could have been caused during explant.Review of the device history record identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic fracture of the right proximal femur with subsequent revision and anatomic alignment.Later femoral and femoral implant fracture with varus angulation.Subsequent revision with anatomic alignment.Bone quality appears osteopenic which could contribute to the fracture.Arthroplasty alignment is maintained on all images.There is femoral implant loosening secondary to the implant shaft and adjacent femur fractures.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: WAGNER SL REVISION HIP STEM, UNCEMENTED, 15/225, 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: 15240115
• Report Number: 0009613350-2022-00420
• Device Sequence Number: 11954143
• Product Code: LZO
• UDI-Device Identifier: 00889024593282
• UDI-Public: (01)00889024593282(17)220228(10)2898989
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00102.215
• Device Lot Number: 2898989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 11/09/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 11/02/2022; 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 62 KG