MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI CLUSTER HOLE CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	502-03-50D
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to shell malposition (it was not reported to the rep if the shell was implanted that way or had migrated).A shell, 2 screws, liner, and head were revised.Rep confirmed there were no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The following devices were also listed in this report: unknown joint replacement screw; cat# unk_jr; lot# unknown, unknown joint replacement screw; cat# unk_jr; lot# unknown, it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding malposition involving a trident shell was reported.The event was confirmed.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: "conclusion/assessment: no medical records or medical data were provided for review.Only a pi report and single unlabeled undated x-ray.The pi report notes a revision surgery for cup malposition.The x-ray shows an acetabular component that is vertical and somewhat anteverted.The cup does looks loose.The stem looks stable.There is a very large femoral head.A revision procedure is not documented.Event confirmation: the event, an acetabular revision, cannot be confirmed as there are no medical records to document the procedure.A likely loose acetabular shell that is vertical and somewhat anteverted is noted.Root cause: a root cause cannot be ascertained as the event 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: conclusion/assessment: no medical records or medical data were provided for review.Only a pi report and single unlabeled undated x-ray.The pi report notes a revision surgery for cup malposition.The x-ray shows an acetabular component that is vertical and somewhat anteverted.The cup does looks loose.The stem looks stable.There is a very large femoral head.A revision procedure is not documented.Event confirmation: the event, an acetabular revision, cannot be confirmed as there are no medical records to document the procedure.A likely loose acetabular shell that is vertical and somewhat anteverted is noted.A root cause cannot be ascertained as the event cannot be confirmed.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: PRIMARY TRIT HEMI CLUSTER HOLE CUP 50MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20704205
• Report Number: 0002249697-2024-01576
• Device Sequence Number: 8293532
• Product Code: JDI
• UDI-Device Identifier: 07613327040135
• UDI-Public: 07613327040135
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2024

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: 09/30/2019
• Device Catalogue Number: 502-03-50D
• Device Lot Number: MNM35Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2014
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 91 KG