MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HMRS PROXIMAL FEMUR BIPOLAR; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_JR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/11/2021

Event Type  Injury  

Event Description

It was reported by the sales rep that patient experienced dislocation from the hmrs proximal femur bipolar and had to have revision surgery.Implanted in 1999 with no implant stickers.Hmrs head was removed and changed to a custom 22mm hmrs head with trident ii tritnanium multihole and constrained liner.Surgeon informed that patient came to hospital with dislocation condition.

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported by the sales rep that patient experienced dislocation from the hmrs proximal femur bipolar and had to have revision surgery.Implanted in 1999 with no implant stickers.Hmrs head was removed and changed to a custom 22mm hmrs head with trident ii titanium multihole and constrained liner.Surgeon informed that patient came to hospital with dislocation condition.

Manufacturer Narrative

Reported event an event regarding disassociation involving an unknown head was reported.The event was confirmed by medical review.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: a photo of an x-ray is provided.It is an ap of the pelvis and it shows a proximal femoral replacement present on the left.The femoral head on the femoral component appears intact but dislocated from the bipolar component.The acetabular appears misshapen and quite thin with upward riding.I can confirm that this event took place since i was able to review the xray showing the dislocation.Regarding the possible root cause of this event, i cannot determine it with certainty.Intra prosthetic dislocation is multifactorial including polyethylene wear, patient factors and surgical technique.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: UNKNOWN HMRS PROXIMAL FEMUR BIPOLAR
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12957244
• MDR Text Key: 286514485
• Report Number: 0002249697-2021-02018
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization