MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII. MODULAR STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 4845-4-106

Device Problem Degraded (1153)

Patient Problems Calcium Deposits/Calcification (1758); Inflammation (1932); Pain (1994); Injury (2348); Depression (2361); Reaction (2414)

Event Date 05/10/2011

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.An unknown mitch acetabular cup 54 insert 60-4 was also reported as part of the event.The mitch trh acetabular system components are oem devices manufactured by depuy.Stryker orthopaedics is not the legal manufacturer of the mitch devices and does not have reporting responsibilities.A voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.Device not available.

Event Description

The lawyer reported that the patient has a dysplasia of the hip, bilateral coxoartrosis, for which he underwent a double intervention of arthroplasty on (b)(6) 2009 right hip.In 2011 due to the strong pains in the right hip, are found para-articular calcifications, so the patient was subjected to several sessions of infiltration.In (b)(6) 2012 the calcifications were removed surgically.On (b)(6) 2013 the patient underwent a revision surgery on the right hip.The patient is reported to have had synovial hyperplasia, metallosis, depression, unanticipated surgical procedure.

Event Description

The lawyer reported that the patient has a dysplasia of the hip, bilateral coxarthrosis, for which he underwent a double intervention of arthroplasty on (b)(6) 2009 right hip.In 2011 due to the strong pains in the right hip, are found para-articular calcifications, so the patient was subjected to several sessions of infiltration.In (b)(6) 2012 the calcifications were removed surgically.On (b)(6) 2013 the patient underwent a revision surgery on the right hip.The patient is reported to have had synovial hyperplasia, metallosis, depression, unanticipated surgical procedure.

Manufacturer Narrative

An event regarding revision due to pain and altr involving an abgii modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device history review: not performed as no lot was provided.Complaint history review: similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.Conclusions voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.The reported revision due to pain and altr is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: ABGII. MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7215193
• MDR Text Key: 98084876
• Report Number: 0002249697-2018-00218
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4845-4-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2089-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR