MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ABG II MODULAR STEM N6; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problem Device-Device Incompatibility (2919)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)

Event Date 02/01/2022

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.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 event is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned to the manufacturer.

Event Description

Patient underwent right thr on (b)(6) 2011.Abg ii modular hip system with an abg11 v0 long neck, abg11 modular stem n6 and ceramic v40 femoral head 36mm were implanted.In (b)(6) 2015/(b)(6) 2016, patient experienced symptoms in her right hip, thigh and knee.Revision surgery was performed on patient's right hip with proximal femoral bone grafting on approx 1/02/2022.Pt reports ongoing pain over right groin area, cobalt poisoning, metallosis, bone loss to proximal part of femur and restricted range of movement.

Event Description

Patient underwent right thr on (b)(6) 2011.Abg ii modular hip system with an abg11 v0 long neck, abg11 modular stem n6 and ceramic v40 femoral head 36mm were implanted.In (b)(6) 2015/(b)(6) 2016, patient experienced symptoms in her right hip, thigh and knee.Revision surgery was performed on patient's right hip with proximal femoral bone grafting on approx (b)(6) 2022.Pt reports ongoing pain over right groin area, cobalt poisoning, metallosis, bone loss to proximal part of femur and restricted range of movement.

Manufacturer Narrative

Reported event: an event regarding pain involving an unknown 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: review of device history records could not be performed as the reported device was not properly identified.-complaint history review: a search of the complaint databases could not be performed as the reported device was not properly identified.Similar events have occurred for the abgii modular 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 pain is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: UNKNOWN ABG II MODULAR STEM N6
• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18208368
• MDR Text Key: 328961828
• Report Number: 0002249697-2023-01459
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 03/12/2024
• 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
• Removal/Correction Number: Z-2089-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female