MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-52D
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection: the device was not returned; however, a photograph was provided for review.The photograph shows a recently explanted shell, completely covered in blood.-clinician review: a review of the provided medical records by a clinical consultant indicated: "as described above, this product inquiry concerns a gentleman who underwent a primary total hip arthroplasty and developed a radiolucency around the cup and underwent revision surgery on (b)(6) 2024, according to the product inquiry summary.I can confirm that the patient underwent a primary total hip arthroplasty since i was able to see an x-ray with the implant in place.I cannot absolutely confirm the revision since i have no documentation such as operation reports, office notes, or post revision x-rays.The root cause of aseptic loosening cannot be determined with certainty.Contributing factors include surgical technique, especially in proper preparation of the acetabular socket.Proper leaning must be carried out in order to obtain a satisfactory scratch fit with a satisfactory bed of cancellous bone.Remote causes that contribute could be patient activity level and bmi.With the information provided i see no implication of the implant itself as a causative factor." -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 was revised due to loosening of the shell.The device was not returned; however, a photograph was provided for review.The photograph shows a recently explanted shell, completely covered in blood.A review of the provided medical records by a clinical consultant indicated: "as described above, this product inquiry concerns a gentleman who underwent a primary total hip arthroplasty and developed a radiolucency around the cup and underwent revision surgery on (b)6) 2024, according to the product inquiry summary.I can confirm that the patient underwent a primary total hip arthroplasty since i was able to see an x-ray with the implant in place.I cannot absolutely confirm the revision since i have no documentation such as operation reports, office notes, or post revision x-rays.The root cause of aseptic loosening cannot be determined with certainty.Contributing factors include surgical technique, especially in proper preparation of the acetabular socket.Proper leaning must be carried out in order to obtain a satisfactory scratch fit with a satisfactory bed of cancellous bone.Remote causes that contribute could be patient activity level and bmi.With the information provided i see no implication of the implant itself as a causative factor." further information such as pathology reports, 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Right total hip arthroplasty revision.Complaints of pain and radiographic demonstration of radiolucency around the acetabular component.Revised for aseptic loosening.Was revised to a competitor cup.Accolade stem retained.

• Brand Name: PRIMARY TRIT HEMI CLUSTER HOLE CUP 52MM
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18619856
• Report Number: 0002249697-2024-00167
• Device Sequence Number: 7444555
• Product Code: LPH
• UDI-Device Identifier: 07613327040128
• UDI-Public: 07613327040128
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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: 12/31/2019
• Device Catalogue Number: 502-03-52D
• Device Lot Number: 5L3XJW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 78 KG