MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_UNKNOWN ACCOLADE TMZF HIP STEM; UNKNOWN HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Corroded (1131); Material Deformation (2976)

Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that the patient's right hip was revised due to pain and elevated cobalt levels.Intra-operatively, surgeon noted corrosion inside the femoral head.Head and liner were revised to an mdm/adm liner construct with a ceramic head and sleeve.Rep provided an explant picture and x-ray and reported that no further information would be released by the hospital or surgeon.

• Brand Name: UNKNOWN_UNKNOWN ACCOLADE TMZF HIP STEM
• Type of Device: UNKNOWN HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: evelyn ryan ; raheen business park; limerick NA ; 61498200
• MDR Report Key: 8422351
• MDR Text Key: 138888278
• Report Number: 0002249697-2019-01341
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 90