MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6565-0-032
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported: "''ceramic head fracture on the left side after 2020, hip tep implanted abroad after falling on the right hip joint in a bathtub.''.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: 'i can confirm that the patient underwent a primary total hip arthroplasty and then subsequently a revision hip arthroplasty on (b)(6) 2025 since i was able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of ceramic head fracture after hip arthroplasty are multi factorial including surgical technique, especially in the way the ceramic head is prepared and implanted, patient factors including activity level, lifestyle and bmi, as well as implant factors.In this case trauma also played role as the patient sustained a fall.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis.' -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported;'ceramic head fracture on the left side after 2020, hip tep implanted abroad in poland after falling on the right hip joint in a bathtub.'' a review of the provided medical records by a clinical consultant indicated: 'i can confirm that the patient underwent a primary total hip arthroplasty and then subsequently a revision hip arthroplasty on (b)(6) 2025 since i was able to review the operation report.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of ceramic head fracture after hip arthroplasty are multi factorial including surgical technique, especially in the way the ceramic head is prepared and implanted, patient factors including activity level, lifestyle and bmi, as well as implant factors.In this case trauma also played role as the patient sustained a fall.Any and all explanted parts or prostheses should be submitted to stryker engineers for complete metallurgical and/or microscopic evaluation and analysis.' no further investigation for this event is possible at this time.If device/additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 23062072
• Report Number: 0002249697-2025-00986
• Device Sequence Number: 9866732
• Product Code: JDI
• UDI-Device Identifier: 04546540402134
• UDI-Public: 04546540402134
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 6565-0-032
• Device Lot Number: 77846201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 72 KG