MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HFX HIP STEM SIZE #10 132; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6070-1035A
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Additional 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.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.Catalog numbers and lot codes of other devices listed in this report: uh1-50-26 uhr bipolar 26x50mm lot h6562t.06-2600 c-taper cocr lfit head 26mm/0 lot j08tw3.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
Event or Problem Description
Patient reported a primary surgery on (b)(6) 2019 and reported severe pain since.Patient would like to know if implants are subject to a recall.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving an omnifit stem was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant indicated: this inquiry concerns a patient who sustained a fracture of the right femoral neck after falling.Surgery was performed with a cementless femoral component and a bipolar hip articulation.The patient continued to complain of pain not so much in the groin but rather in the right thigh.The patient had concomitant spine issues and diagnostic spinal injections alleviated 100% of the patient's pain.The patient however continued to complain of pain and was seen by another orthopedic surgeon who diagnosed a "possible loose femoral prosthesis." no supporting documentation for that diagnosis was given except some ¿stress lines more distal than proximal¿.The surgeon recommended revision surgery.I can confirm that the patient sustained a femoral neck fracture which was treated with a cementless bipolar arthroplasty since i was able to see the preoperative and postoperative x rays.I have no further x-rays to evaluate so i cannot confirm any possible changes in the position or configuration of the implant, especially the ¿stress lines more distal than proximal¿.A consulting orthopedic surgeon diagnosed a "possible loose femoral component" with no supporting documentation and no x-ray findings suggestive of loosening except some ¿stress lines more distal than proximal¿.No workup for infection or any other cause was presented.I cannot determine the root cause of this event with certainty.This patient had spinal injections which relieved her symptoms 100%.The patient never had an intra-articular injection with an anesthetic which would help to corroborate pain from the acetabular portion of the implant.As i mentioned above, i have no further x-rays to examine that might implicate any problems with the implant itself.The causes of pain following cementless bipolar arthroplasty are multifactorial.These include loosening, infection, pain from an un-resurfaced acetabulum and pain from remote sources such as the spine and stress fracture.Also, causes include surgical technique, patient factors including activity level and bmi, and implant factors.-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 lot referenced.Conclusion: it is also noted that the patient inquired if their devices are subject to a recall.Based on the catalog and lot information provided the product is not subject to a product recall.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 or Problem Description
Patient reported a primary surgery on (b)(6) 2019 and reported severe pain since.Patient would like to know if implants are subject to a recall.

• Brand Name: OMNIFIT HFX HIP STEM SIZE #10 132
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15342530
• Report Number: 0002249697-2022-01290
• Device Sequence Number: 5037984
• Product Code: LPH
• UDI-Device Identifier: 07613327023442
• UDI-Public: 07613327023442
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K031744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2022

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: 02/28/2024
• Device Model Number: 6070-1035A
• Device Catalogue Number: 6070-1035A
• Device Lot Number: EA8E8V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 12/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 106 KG