MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 11MM PRESS FIT FLUTED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6495-5-011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a revision for broken gmrs 11 x 125 press fit femur stem on right leg.Revision was performed due to the stem breaking where the 11mm diameter begins tapering to a wider diameter.The stem, an extender, femoral component, and rotating component were revised.
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.A supplemental report will be provided upon completion of the investigation.
Event or Problem Description
Patient had a revision for broken gmrs 11 x 125 press fit femur stem on right leg.Revision was performed due to the stem breaking where the 11mm diameter begins tapering to a wider diameter.The stem, an extender, femoral component, and rotating component were revised.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a gmrs stem was reported.The event was confirmed via evaluation of the returned devices and clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis and indicated the following: "image shows the straight fluted press-fit stem with fracture location highlighted by the arrow.On visual examination, the fracture was observed approximately 38 mm from the male taper at the distal end of the stem.Also included in the image are the extension piece, femoral component and tibial rotating component.Figure shows an overview image of the fracture surface." material analysis: a material analysis was performed which concluded the following: "review of gmrs straight fluted press-fit stem, catalogue # 6495-5-011, lot code 170652b confirmed fracture of the stem.Characterisation using visual and stereo microscopy examination confirmed fracture near the distal end of the stem.Stereo microscopy analysis suggests the fracture propagated in fatigue." -clinician review: a review of the provided medical information by a clinical consultant indicated: "the implant records confirm that the patient had multiple revisions of the tka including a liner exchange and a revision for a broken stem.The x-rays and in particular the ap which demonstrates and angulated stem is consistent with material failure of the stem.The root cause of these failures cannot be determined from the limited documentation provided." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the gmrs stem.A material analysis was performed which concluded the following: "review of gmrs straight fluted press-fit stem, catalogue # 6495-5-011, lot code 170652b confirmed fracture of the stem.Characterisation using visual and stereo microscopy examination confirmed fracture near the distal end of the stem.Stereo microscopy analysis suggests the fracture propagated in fatigue." the event was further confirmed by clinician review of the provided x-ray image.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 11MM PRESS FIT FLUTED STEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17948184
• Report Number: 0002249697-2023-01210
• Device Sequence Number: 15205356
• Product Code: LZO
• UDI-Device Identifier: 07613327033489
• UDI-Public: 07613327033489
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 6495-5-011
• Device Lot Number: 170652B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 02/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 114 KG