MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 2, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to hip stem fracture in the proximal area, directly after the cone.Stem head and liner were replaced.Due diligence is in progress for this complaint; to date no additional information has been received.
Additional Manufacturer Narrative
(b)(4).D10 ¿ unknown liner; item# unknown, lot# unknown.Unknown head 59/28; item# unknown, lot# unknown.G2 ¿ foreign ¿ switzerland.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No additional information at this time.
Additional Manufacturer Narrative
(b)(4).The visual examination of the stem revealed that the coated area of the stem shows well-distributed remains of bone on growth.Further, there are drill marks, scratches and a cut from the revision surgery on the coated area.The stem neck shows extensive scratches and dents, most likely from the revision surgery.The stem is fractured, with the fracture running through the neck of the stem.Both fracture surfaces show large polished areas, which are most likely due to the contact of the fracture parts after the fracture.The fracture surfaces show fine progression lines, indicating a fatigue fracture originating on the lateral side.A review of the device manufacturing records confirmed no abnormalities or deviations.The device labeling of the returned femoral head and polyethylene liner revealed that both products are from smith&nephew.According to the instruction leaflet for endoprostheses d011500 200 ed.05/09, which was delivered together with the stem, only authorized combinations of implants and components made or distributed by zimmer companies must be used.Therefore, this combination has not been confirmed to be approved/cleared for use and is considered off-label usage.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.An undated single ap view of the right hip was provided and reviewed by a health care professional (radiologist).The review identified a fracture of the femoral implant at the lower neck.There is varus alignment secondary to the femoral implant fracture.Bone quality is osteopenic.It is unknown if the off-label usage may have caused or contributed to the implant fracture.Therefore, as the cause of the fracture may be multifactorial consisting of patient and/or procedure-related factors (incl.Component selection), a definitive root cause could not 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.

• Brand Name: AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 2, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• 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: 17806504
• Report Number: 0009613350-2023-00531
• Device Sequence Number: 17937906
• Product Code: LZO
• UDI-Device Identifier: 00889024288140
• UDI-Public: (01)00889024288140(17)170331(10)4018887
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K123392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 01/19/2024

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: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 0106010102
• Device Lot Number: 4018887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2012
• 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
• Patient Age: 47 YR
• Patient Sex: Female