MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH INT SHFT&STEM OVLCOL 15X30X38C; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number MSISS-O15X30X38C

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 01/19/2024

Event Type  Injury  

Event Description

Sales rep report as below: "x-ray appears to show dislocation and separation of the two implants (stanmore proximal femoral replacement).

Manufacturer Narrative

An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.H3 other text : not available.

Event Description

Sales rep report as below: "x-ray appears to show dislocation and separation of the two implants (stanmore proximal femoral replacement).".

Manufacturer Narrative

Reported event: an event regarding disassociation involving a mets proximal femur replacement, integral shaft & stem was reported.The event was confirmed via clinician review of the provided medical records.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 information by a clinical consultant indicated: "conclusion/assessment: no medical information, patient history, pre or postoperative radiographs, or other history were provided for review.The evaluation was solely based on the pi event description, and a single unlabeled x-ray of a hip/acetabulum.Based on the pi report and the x-ray there was a dislocation of an implant from the acetabulum and an apparent dissociation of a proximal modular piece of the femur.Event confirmation: a dislocation, and dissociation of a proximal implant can be confirmed.The entirety of the device cannot be viewed.Root cause: the root cause of the event cannot be determined as no clinical information, preoperative or postoperative evaluations, or radiographs were provided for evaluation." -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 an x-ray showed dislocation and separation of two implants.A review of the provided medical records by a clinician indicated the following: "based on the pi report and the x-ray there was a dislocation of an implant from the acetabulum and an apparent dissociation of a proximal modular piece of the femur.Event confirmation: a dislocation, and dissociation of a proximal implant can be confirmed.The entirety of the device cannot be viewed.Root cause: the root cause of the event cannot be determined as no clinical information, preoperative or postoperative evaluations, or radiographs were provided for evaluation." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: INT SHFT&STEM OVLCOL 15X30X38C
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18700444
• MDR Text Key: 335294137
• Report Number: 0002249697-2024-00222
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: MSISS-O15X30X38C
• Device Lot Number: B33895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other