MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-50E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Visual Impairment (2138); Taste Disorder (4422); Joint Laxity (4526)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a trident shell was reported.The event was confirmed via evaluation of the provided medical records by a clinical consultant.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 the provided medical information by a clinical consultant indicated: "based upon the information received on august 9, 2022, including a series of x-ray images and some office notes, i can confirm that the patient does have a failed left total hip arthroplasty due to malposition of the acetabular component with polyethylene wear.While the office notes state that the patient is a candidate for revision surgery, there is no evidence presented that confirms that revision surgery took place.Regarding the root causes of failure of a total hip arthroplasty due to acetabular malposition and polyethylene wear, the causes are multifactorial.They include surgical technique including increased verticality of the acetabular component, the activity level and the bmi of the patient, and implant factors.Serial x-rays would have to be examined in order to see if increased verticality of a cup was present for a significant length of time which could contribute to polyethylene wear." 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: it was reported that the patient is to be revised due to malposition of the shell and wear of the liner.A review of the provided medical information by a clinical consultant indicated: "based upon the information received on august 9, 2022, including a series of x-ray images and some office notes, i can confirm that the patient does have a failed left total hip arthroplasty due to malposition of the acetabular component with polyethylene wear.While the office notes state that the patient is a candidate for revision surgery, there is no evidence presented that confirms that revision surgery took place.Regarding the root causes of failure of a total hip arthroplasty due to acetabular malposition and polyethylene wear, the causes are multifactorial.They include surgical technique including increased verticality of the acetabular component, the activity level and the bmi of the patient, and implant factors.Serial x-rays would have to be examined in order to see if increased verticality of a cup was present for a significant length of time which could contribute to polyethylene wear." the patient also is requesting whether the implanted devices are part of a recall.Based on the catalog and lot number provided, the reported device is not subject to a product recall.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.Device not returned to the manufacturer.
Event or Problem Description
Patient reported he had a left tha on (b)(6) 2013.Patient started to experience popping when walking and vision issues approx two years ago.In (b)(6) of 2021 his taste buds changed and he started to experience pain.Patient stated he has been unable to work since (b)(6) 2022 due to his pain.Patient would like to know if his implants are part of a recall.Update per conversation with patient: patient stated he was experiencing vision problems, muscle aches and popping of hip.Update 29-september-2022 mf: per medical review: "the femoral component and femoral head appear satisfactory.The acetabular component is malpositioned with what appears to be almost a completely vertical position.There appears to be some polyethylene wear."the medical records further indicate that revision surgery is recommended.
Event or Problem Description
Patient reported he had a left tha on (b)(6) 2013.Patient started to experience popping when walking and vision issues approx two years ago.In dec of 2021 his taste buds changed and he started to experience pain.Patient stated he has been unable to work since (b)(6) 2022 due to his pain.Patient would like to know if his implants are part of a recall.Update per conversation with patient: patient stated he was experiencing vision problems, muscle aches and popping of hip.Update (b)(6) 2022 mf: per medical review: "the femoral component and femoral head appear satisfactory.The acetabular component is malpositioned with what appears to be almost a completely vertical position.[.] there appears to be some polyethylene wear."the medical records further indicate that revision surgery is recommended.
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a trident shell was reported.The event was confirmed via evaluation of the provided medical records by a clinical consultant.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 the provided medical information by a clinical consultant indicated: "based upon the information received on august 9, 2022, including a series of x-ray images and some office notes, i can confirm that the patient does have a failed left total hip arthroplasty due to malposition of the acetabular component with polyethylene wear.While the office notes state that the patient is a candidate for revision surgery, there is no evidence presented that confirms that revision surgery took place.Regarding the root causes of failure of a total hip arthroplasty due to acetabular malposition and polyethylene wear, the causes are multifactorial.They include surgical technique including increased verticality of the acetabular component, the activity level and the bmi of the patient, and implant factors.Serial x-rays would have to be examined in order to see if increased verticality of a cup was present for a significant length of time which could contribute to polyethylene wear." -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: it was reported that the patient is to be revised due to malposition of the shell and wear of the liner.A review of the provided medical information by a clinical consultant indicated: "based upon the information received on august 9, 2022, including a series of x-ray images and some office notes, i can confirm that the patient does have a failed left total hip arthroplasty due to malposition of the acetabular component with polyethylene wear.While the office notes state that the patient is a candidate for revision surgery, there is no evidence presented that confirms that revision surgery took place.Regarding the root causes of failure of a total hip arthroplasty due to acetabular malposition and polyethylene wear, the causes are multifactorial.They include surgical technique including increased verticality of the acetabular component, the activity level and the bmi of the patient, and implant factors.Serial x-rays would have to be examined in order to see if increased verticality of a cup was present for a significant length of time which could contribute to polyethylene wear." the patient also is requesting whether the implanted devices are part of a recall.Based on the catalog and lot number provided, the reported device is not subject to a product recall.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: TRIDENT PSL WITH PUREFIX HA 50MM
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15648774
• Report Number: 0002249697-2022-01529
• Device Sequence Number: 2381366
• Product Code: LPH
• UDI-Device Identifier: 07613327037265
• UDI-Public: 07613327037265
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: 01/31/2018
• Device Model Number: 542-11-50E
• Device Catalogue Number: 542-11-50E
• Device Lot Number: MLTD31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 93 KG