MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RELIANCE CM CEMENTED HIP #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6265-3-112
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding stem loosening involving a reliance stem was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs display a recently explanted stem, ceramic head and ceramic lined shell.There is no visible damage to note on the devices.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: need operative reports, office/clinical reports, serial x-rays, etc.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, office/clinical reports, serial x-rays and evaluation of the explanted devices are needed to complete the investigation for determining root cause.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.
Event or Problem Description
It was reported that the patient's right hip was revised due to loosening of the femoral stem.Intra-operatively, the stem was easily removed from the patient.The stem (originally cemented with simplex p cement), ceramic head, and ceramic.Liner were revised to an adm/ mdm liner construct and competitor stem and head.Rep confirmed there are no allegations against the revised head and liner.

• Brand Name: RELIANCE CM CEMENTED HIP #2
• 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: 8975907
• Report Number: 0002249697-2019-03143
• Device Sequence Number: 2883701
• Product Code: LPH
• UDI-Device Identifier: 04546540262868
• UDI-Public: 04546540262868
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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: 01/31/2002
• Device Catalogue Number: 6265-3-112
• Device Lot Number: C5RJB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/09/2019
• 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: 60 YR