MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOCLASSIC SL STEM, OFFSET, UNCEMENTED, 6, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to a pp (periprosthetic fracture) fracture, approximately 5 years and 6 months post-implantation.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).D10/d11: concomitant medical products: durasul, alpha insert, hooded, mm/28, ref# (b)(4), lot#68152.Allofit alloclassic, shell with polar screw plug, uncemented, 60/mm, ref# (b)(4), lot# 2746740.Cocr head, xl, 28/+8, taper 12/14; ref# (b)(4), lot#2637601.G2- 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
(b)(4).This follow-up report is being submitted to relay additional information.D10: durasul, alpha insert, hooded, mm/28; ref(b)(4); lot#2868152.Allofit alloclassic, shell with polar screw plug, uncemented, 60/mm; ref#(b)(4); lot#2746740.Cocr head, xl, 28/+8, taper 12/14; ref#(b)(4); lot#2637601.It was reported that the patient was implanted with an alloclassic stem on (b)(6) 2018 and underwent revision surgery on (b)(6) 2023 due to a periprosthetic bone fracture due to a fall.The product was not returned, but an image was received which shows the removed alloclassic stem with the mounted cocr head.Both parts are covered in blood and tissue remains; therefore, a detailed assessment could not be performed.The visible surfaces appear inconspicuous.A review of the device manufacturing records of the stem confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Medical records were not provided.Based on the provided information, the most likely root cause of the reported issue is attributed to the patient's fall.No corrective, preventive or field action was taken following the investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental 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: ALLOCLASSIC SL STEM, OFFSET, UNCEMENTED, 6, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED
• 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: 17919811
• Report Number: 0009613350-2023-00573
• Device Sequence Number: 2971149
• Product Code: LZO
• UDI-Device Identifier: 00889024590410
• UDI-Public: (01)00889024590410(17)200630(10)2821560
• 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: 2018
• 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): 02/05/2024

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: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 01.00121.060
• Device Lot Number: 2821560
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 90 KG