MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HFX HIP STEM SIZE #09 132; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number 6070-0935A

Device Problem Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 12/22/2021

Event Type  Injury  

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 Description

51mm bipolar, 28mm +0 c taper cocr head, and 9/132 omnifit hfx pressfit application stem were used in a hemiarthroplasty on (b)(6) 2021.On tuesday 12/21/21 i was contacted by dr, who did the hemi, indicating the patient dislocated, and we would be revising the case.A 51mm bipolar, 28 +5 cocr c taper head, and 7/132 omnifit eon cemented stem was implanted on (b)(6) 2021, all implants from the primary hemi were explanted.They are not available for return as per hospital policy.

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 Description

51mm bipolar, 28mm +0 c taper cocr head, and 9/132 omnifit hfx pressfit application stem were used in a hemiarthroplasty on (b)(6) 2021.On tuesday 12/21/2021 i was contacted by dr, who did the hemi, indicating the patient dislocated, and we would be revising the case.A 51mm bipolar, 28 +5 cocr c taper head, and 7/132 omnifit eon cemented stem was implanted on (b)(6) 2021, all implants from the primary hemi were explanted.They are not available for return as per hospital policy.

Manufacturer Narrative

Reported event: an event regarding revision for unspecified reasons involving a omnifit stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the medical records by a clinical consultant indicated "i can confirm that a dislocation of the implant took place since i was able to review xrays that showed the dislocation.I have no explanation why the surgeon found it necessary to remove the femoral implant.Regarding the possible root cause of this event, dislocation in the immediate post-operative period, in the absence of trauma, is almost always surgical technique related.No implant related issues apply in this case." -device 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 reported lot.Conclusion: the event could not be confirmed as insufficient information was provided.Further information such as the reason for the revision surgery, operative reports as well as return of the device are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

51mm bipolar, 28mm +0 c taper cocr head, and 9/132 omnifit hfx pressfit application stem were used in a hemiarthroplasty on (b)(6) 2021.On (b)(6) 2021 i was contacted by dr, who did the hemi, indicating the patient dislocated, and we would be revising the case.A 51mm bipolar, 28 +5 cocr c taper head, and 7/132 omnifit eon cemented stem was implanted on (b)(6) 2021, all implants from the primary hemi were explanted.They are not available for return as per hospital policy.

• Brand Name: OMNIFIT HFX HIP STEM SIZE #09 132
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: 13262663
• MDR Text Key: 286233317
• Report Number: 0002249697-2022-00093
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 07613327023459
• UDI-Public: 07613327023459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031744
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6070-0935A
• Device Catalogue Number: 6070-0935A
• Device Lot Number: 8E4DX7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• 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
• Patient Age: 93 YR
• Patient Sex: Female