MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN RESTORATION MODULAR CONE BODY; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

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

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by mfr: device not available.

Event Description

As reported: 'revision tha due to elevated metal levels in patient's blood.36 +5 metal head (lfit v40) on rest mod proximal cone body.Revised due to before mentioned metal levels." head in liner were revised to biolox head and sleeve as well as a stryker liner.Spoke to rep.Surgeon reported previous revision of a competitor metal-on-metal construct and was unsure if elevated metal levels were caused by that construct.

• Brand Name: UNKNOWN RESTORATION MODULAR CONE BODY
• Type of Device: 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8429295
• MDR Text Key: 139096197
• Report Number: 0002249697-2019-01365
• Device Sequence Number: 1
• Product Code: KWY
• 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: 03/18/2019

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
• 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: 02/18/2019
• Initial Date FDA Received: 03/18/2019
• 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: 72