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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ABG II MODULAR STEM N6; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
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.
 
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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 Key18208368
MDR Text Key328961828
Report Number0002249697-2023-01459
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
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 NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/01/2023
Initial Date FDA Received11/27/2023
Supplement Dates Manufacturer Received02/16/2024
Supplement Dates FDA Received03/12/2024
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 NumberZ-2089-2012
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age71 YR
Patient SexFemale
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