MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 135-DEGREE ABGII MODULAR NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problem Device-Device Incompatibility (2919)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 01/04/2023

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a rtha with abgii modular in (b)(6) 2011 experienced osteolysis, necrosis, adverse local tissue reaction and pain.Plaintiff underwent girdlestone surgery on (b)(6) 2021.During the procedure it was noted ¿posterior wall was quite deficient, the superior dome was intact but there was a medical wall defect¿¿.¿the modular neck was removed¿and found to be coated with black material.Severe bone destruction was noted around the acetabular at this time.¿ ¿in (b)(6) 2011, the plaintiff underwent a surgery to attempt to implant an artificial pelvic model.However, this procedure was unsuccessful and the plaintiff has been left wheelchair bound.¿.

Manufacturer Narrative

Reported event: an event regarding altr involving a abgii modular device was reported.The event was confirmed.Method & results: device evaluation and results:material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Device history review: not performed as device was not properly identified.Complaint history review: not performed as device was not properly identified.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 altr is considered to be under the scope of this recall.No further investigation is required.Device not returned to the manufacturer.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a rtha with abgii modular in june of 2011 experienced osteolysis, necrosis, adverse local tissue reaction and pain.Plaintiff underwent girdlestone surgery on may 19, 2021.During the procedure it was noted ¿posterior wall was quite deficient, the superior dome was intact but there was a medical wall defect¿¿.¿the modular neck was removed¿and found to be coated with black material.Severe bone destruction was noted around the acetabular at this time.¿ ¿in (b)(6) 2021, the plaintiff underwent a surgery to attempt to implant an artificial pelvic model.However, this procedure was unsuccessful and the plaintiff has been left wheelchair bound.¿.

Manufacturer Narrative

Reported event: an event regarding altr involving a abgii modular device was reported.The event was confirmed.Method & results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Device history review: not performed as device was not properly identified.Complaint history review: not performed as device was not properly identified.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 altr is considered to be under the scope of this recall.No further investigation is required.

• Brand Name: UNKNOWN 135-DEGREE ABGII MODULAR NECK
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16261330
• MDR Text Key: 308345076
• Report Number: 0002249697-2023-00079
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/08/2023

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: 01/04/2023
• Initial Date FDA Received: 01/28/2023
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 02/08/2023
• 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 Sex: Female