MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-56E
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
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 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.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised due to loosening of the shell.The shell, liner, and femoral head were revised.Rep provided an x-ray and primary usage, and confirmed that there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident shell was reported.The event was 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: a review of the provided medical records and x-rays by a clinical consultant indicated: x-rays show lucencies in all 3 gruen zones about the acetabulum consistent with aseptic loosening.No obvious cause for this relatively early loss of fixation ( implanted in 2016).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: a review of the provided medical records and x-rays by a clinical consultant indicated: x-rays show lucencies in all 3 gruen zones about the acetabulum consistent with aseptic loosening.No obvious cause for this relatively early loss of fixation (implanted in 2016).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.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to loosening of the shell.The shell, liner, and femoral head were revised.Rep provided an x-ray and primary usage, and confirmed that there are no allegations against the revised head and liner, and that no further information will be released by the hospital or surgeon.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
• 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: 10808300
• Report Number: 0002249697-2020-02372
• Device Sequence Number: 17019446
• Product Code: LPH
• UDI-Device Identifier: 07613327040166
• UDI-Public: 07613327040166
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: 02/28/2021
• Device Model Number: 502-03-56E
• Device Catalogue Number: 502-03-56E
• Device Lot Number: 8002K8
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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 Age: 53 YR
• Patient Weight: 104