MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ABG II MODULAR STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)

Event Date 11/23/2010

Event Type  Injury  

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. Device not returned.

Event Description

Patient called stating she had a left hip replacement done (b)(6) 2010. Patient is currently experiencing pain and reported that a blood test indicated metallosis. She would like to know if her implants are part of a recall.

• Brand Name: UNKNOWN ABG II MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; NA
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9105191
• MDR Text Key: 163755628
• Report Number: 0002249697-2019-03287
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,OTHER

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/23/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNK_JR
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated By Manufacturer?: No
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2089-2012

Patient TREATMENT DATA

Date Received: 09/23/2019 Patient Sequence Number: 1