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

Model Number	502-03-50D
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
Necrosis of the left femoral head.First surgery on (b)(6) 2013.Tha.Tritanium cup was implanted.It caused loosening and migration.It was replaced on (b)(6) 2020.
Event or Problem Description
Necrosis of the left femoral head.First surgery on (b)(6), 2013.Tha.Tritanium cup was implanted.It caused loosening and migration.It was replaced on (b)(6), 2020.
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: a visual, functional and dimensional inspection could not be performed as the product was not returned.Clinician review: the available medical records were provided to the consulting clinician for a review which noted, " no clinical or pmh, no operative reports, no examination of explanted components, no surgical pathology or laboratory reports.Based upon the 2 poor quality x-ray images, confirmation of acetabular component migration as noted in the event description can be made, but insufficient data is presented to create a medical report for this case." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that the patient was revised due to loosening and migration.The available medical records were provided to the consulting clinician for a review which noted that no clinical or pmh, no operative reports, no examination of explanted components, no surgical pathology or laboratory reports.Based upon the 2 poor quality x-ray images, confirmation of acetabular component migration as noted in the event description can be made, but insufficient data is presented to create a medical report for this case.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, pre- and post-op x-rays, patient history, histopathology report & follow-up notes are needed to investigate this event further.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopedics.If additional information and/or device becomes available, this investigation will be reopened.H3 other text : device not returned.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10536045
• Report Number: 0002249697-2020-01916
• Device Sequence Number: 2940481
• Product Code: LPH
• UDI-Device Identifier: 07613327040135
• UDI-Public: 07613327040135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 07/31/2018
• Device Model Number: 502-03-50D
• Device Catalogue Number: 502-03-50D
• Device Lot Number: 44568301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 53