MAUDE Adverse Event Report: ZIMMERSWITZERLAND MANUFACTURING GMBH ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 0, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	01.00121.000
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision surgery approximately nine years after the initial implantation due to osteolysis and loosening of the implant.Due diligence is in progress for this complaint; to date what additional information that was received has been mentioned in this report, no product has been received yet.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: versys 32mm (+7) 12/14 taper; item# 8018-32-14; lot# 62516810.Trilogy liner std 32mm id for 56mm od shell; item# 6305-56-32; lot# 62621308.Initial reporter country- foreign: australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.A radiograph was provided and reviewed by a radiologist who confirmed that there were no obvious periprosthetic lucencies/osteolysis.The operational report was provided and reviewed by a health care professional.Findings as follows: ¿ loose femoral left hip prosthesis ¿ femoral component and liner exchanged ¿ spinal/sedation ¿ previous incision utilized, no evidence of infection, samples sent to path ¿ no wear to liner ¿ femoral component loose and extracted with minor greater trochanter tip fracture cable to calcar prophylactically ¿ after components placed noted calcar fracture despite prophylactic cable, no distal extension, component stable ¿ wbat (weight bearing as tolerated).With the available information, 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
It was reported the patient underwent revision of initial left total hip arthroplasty, approximately nine years after the initial implantation due to osteolysis and loosening.During the procedure noted femoral component loose and greater trochanter and calcar fracture while explanting and implanting new stem, despite cerclage cable being place prophylactically.Attempts have been made and no further information has been provided.

• Brand Name: ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMERSWITZERLAND 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: 16512573
• Report Number: 0009613350-2023-00108
• Device Sequence Number: 20412125
• Product Code: LZO
• UDI-Device Identifier: 00889024590458
• UDI-Public: (01)00889024590458(17)150228(10)2546573
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K193050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 04/25/2023

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: 02/28/2015
• Device Model Number: 01.00121.000
• Device Catalogue Number: 0100121000
• Device Lot Number: 2546573
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male