MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Swelling/ Edema (4577)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt.Called and reported that; the part that was replaced is no good.It's giving me problems.It's been two or three years and the doctor keeps just denying it and he knows that it's not right.I can't even walk on my leg, it's numb from all the way down and i need somebody to verify this part to see if some of these parks have been recalled.I was told two years ago that one of them had been recalled and this is striker picture of this part that i was told that had been replaced several years ago.And it's reference # 626-9 dash 128 and the lot number 796-0320 to.And it's the femoral head lfit 3:40 pmtm above each one of those and it's strikers.And i would appreciate a call from somebody to verify something about if this was recalled or has it been recalled.It doesn't matter what year this guy told me.It had been several years i thought he said 2013 or 2015, but i was so excited.I was so upset when they told me it had been recalled and i just.I went to pieces.I need to know a fact about this.Hip and leg is swollen and hurts.
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.
Event or Problem Description
Pt.Called and reported that; the part that was replaced is no good.It's giving me problems.It's been two or three years and the doctor keeps just denying it and he knows that it's not right.I can't even walk on my leg, it's numb from all the way down and i need somebody to verify this part to see if some of these parks have been recalled.I was told two years ago that one of them had been recalled and this is striker picture of this part that i was told that had been replaced several years ago.And it's reference #(b)(4) and the lot number 796-0320 to.And it's the femoral head lfit 3:40 pmtm above each one of those and it's strikers.And i would appreciate a call from somebody to verify something about if this was recalled or has it been recalled.It doesn't matter what year this guy told me.It had been several years i thought he said 2013 or 2015, but i was so excited.I was so upset when they told me it had been recalled and i just.I went to pieces.I need to know a fact about this.Hip and leg is swollen and hurts.
Additional Manufacturer Narrative
An event regarding pain involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of medical records with a clinical consultant indicated "a patient underwent hemiarthroplasty for a displaced femoral neck fracture.The surgery and immediate postoperative course seemed uneventful.The preoperative and postoperative medical history were not provided for review.No radiographs were provided for review.The patient complains of pain, swelling, numbness and difficulty walking.There was an inquiry regarding recall of implants.Event confirmation: a femoral neck fracture and hemiarthroplasty can be confirmed.The patient complaints and assertion of device recall cannot be confirmed.Root cause: the root cause of the hemiarthroplasty was a displaced right femoral neck fracture.A root cause of the complaints cannot be ascertained as the events cannot be confirmed.-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: a review of medical records with a clinical consultant indicated "a patient underwent hemiarthroplasty for a displaced femoral neck fracture.The surgery and immediate postoperative course seemed uneventful.The preoperative and postoperative medical history were not provided for review.No radiographs were provided for review.The patient complains of pain, swelling, numbness and difficulty walking.There was an inquiry regarding recall of implants.Event confirmation: a femoral neck fracture and hemiarthroplasty can be confirmed.The patient complaints and assertion of device recall cannot be confirmed.Root cause: the root cause of the hemiarthroplasty was a displaced right femoral neck fracture.A root cause of the complaints cannot be ascertained as the events cannot be confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary 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.

• Brand Name: 28MM STD LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19939786
• Report Number: 0002249697-2024-01104
• Device Sequence Number: 7332409
• Product Code: JDI
• UDI-Device Identifier: 07613327013023
• UDI-Public: 07613327013023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 6260-9-128
• Device Lot Number: 79603206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2020
• 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: Hospitalization; Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White