MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 22X42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number UH1-42-22

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 09/21/2023

Event Type  Injury  

Event Description

Patient complaint about left hip pain and was unable to walk.Xray shows that she is suffering from protusio of bipolar implant inserted in (b)(6) 2016.Dr.Performed a thr revision procedure for her.We only got to know stryker implant was inserted intra-op.Procedure: left thr revision.

Manufacturer Narrative

The following devices were also listed in this report: exeter v40 stem 33mm; cat # 0580-1-330; lot # unknown.22.2mm std lfit v40 head; cat # 6260-9-122; lot # unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.H3 other text : not available.

Manufacturer Narrative

Reported event: an event regarding malposition/protrusio involving a uhr head 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 records by a clinical consultant indicated: "the md communication states that the patient's problem started in 2016 with a hip fracture.This was treated with a hemiarthroplasty.In the letter, and borne out by x-ray review, this hemiarthroplasty was seen to mechanically fail with severe osteolysis and superior and medial cup migration and protrusio.Postoperative x-rays demonstrate a cup/cage acetabular reconstruction with bone grafting and lateral plating of the femur.Mechanical failure of a left hip hemiarthroplasty with subsequent revision is confirmed.The root cause of this failure cannot be determined from the information provided.[¿] i cannot state with certainty the reason for the plate as i do not have an operative report related to this surgery.That being said on multiple pre-operative x-rays severe osteolysis is seen in the trochanteric and subtrochanteric x-rays.Review of the post-operative x-rays do not reveal any evidence of fracture.Therefore i strongly believe the plating was prophylactic in nature." -product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to pain and protrusio of the bipolar implant.A review of the provided medical records by a clinical consultant indicated: "in the letter, and borne out by x-ray review, this hemiarthroplasty was seen to mechanically fail with severe osteolysis and superior and medial cup migration and protrusio.Postoperative x-rays demonstrate a cup/cage acetabular reconstruction with bone grafting and lateral plating of the femur.Mechanical failure of a left hip hemiarthroplasty with subsequent revision is confirmed.The root cause of this failure cannot be determined from the information provided." further information such as return of the device, pathology reports, additional serial pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.

Event Description

Patient complaint about left hip pain and was unable to walk.Xray shows that she is suffering from protusio of bipolar implant inserted in (b)(6) 2016.Dr.Performed a thr revision procedure for her.We only got to know stryker implant was inserted intra-op.Procedure: left thr revision.

• Brand Name: UHR BIPOLAR 22X42MM
• 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: 17937955
• MDR Text Key: 325674992
• Report Number: 0002249697-2023-01194
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K800207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UH1-42-22
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: Asian