MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 5, TAPER 12/14; COATED HIP FEMUR PROSTHESIS, MODULAR

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - israel.D10: unknown zimmer head, item#: unknown, lot#: unknown.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Insufficient information provided.Unable to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were not provided.With the available information, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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
It was reported that the patient underwent implantation with hip prostheses approximately 2-9 years ago.Postoperatively, after falling, the patient experienced periprosthetic fractures.During revision a non union of hip stem with the bone was noticed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.A review of the additional information received does not alter the findings of the previously reported investigation.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
It was reported that a patient underwent hip prostheses implantation approximately ten (10) years ago.About nine (9) years later, by sitting on a bench that collapsed, patient fell to the ground and sustained a b2 periprostetic fracture.The patient underwent revision of the femoral component.There was minimal bone ingrowth on the removed stem.Attempts have been made and no further information has been provided.

• Brand Name: AVENIR MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 5, TAPER 12/14
• Common Device Name: COATED HIP FEMUR PROSTHESIS, MODULAR
• 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: 17223945
• Report Number: 0009613350-2023-00341
• Device Sequence Number: 7177582
• Product Code: LZO
• UDI-Device Identifier: 00889024591004
• UDI-Public: (01)00889024591004(17)170630(10)4019309
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 01.06010.105
• Device Lot Number: 4019309
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2012
• 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; Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 65 KG