MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-54E
Medical Device Problem Codes	Osseointegration Problem (3003); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.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.
Event or Problem Description
It was reported that the patient's left hip was revised due to progressive gait instability.A tritanium cluster 54mm cup, 3 screws, and liner were revised.There are no allegations against the liner.Spoke to rep, who provided a pre-revision x-ray.Rep confirmed no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a trident shell was reported.The event was not confirmed but loosening was confirmed by medical review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: rejected for medical review undated x-ray confirms loosening of acetabular component, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components product history review: not be performed as lot code information was invalid complaint history review: not be performed as lot code information was invalid conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details and return, pathology reports, pre- and post-operative x-rays and the primary 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 as no devices and insufficient information was received by stryker orthopaedics.If devices and or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left hip was revised due to progressive gait instability.A tritanium cluster 54mm cup, 3 screws, and liner were revised.There are no allegations against the liner.Spoke to rep, who provided a pre-revision x-ray.Rep confirmed no further information will be released by the hospital or surgeon.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
• 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: 9075127
• Report Number: 0002249697-2019-03218
• Device Sequence Number: 2312625
• Product Code: LPH
• UDI-Device Identifier: 07613327040142
• UDI-Public: 07613327040142
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 03/31/2015
• Device Catalogue Number: 502-03-54E
• Device Lot Number: MHRAWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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: 70 YR