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

Catalog Number 4845-4-103

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/11/2020

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 review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.

Event Description

It has been reported - the patient who underwent right hip replacement surgery in (b)(6) 2010.Consultation in early 2020 for painful symptoms.The polyethylene component of her prosthesis was found to be very worn, with a very probable risk of metallosis, which could be the cause of her pain.

Manufacturer Narrative

Reported event: an event regarding abnormal ion levels involving a abgii modular device was reported.The event was confirmed.Method & results: device evaluation and results: material analysis: visual inspection of the provided images has been performed and stated that - white arrows point out the change in surface appearance where the stem was inserted into the femoral implant.A black arrow points to the feature called the trunnion; it appears clean and undamaged.Mar has been provided for returned product and stated that - evidence was found of metallosis, (an interaction between implanted alloys and body tissue and/or fluid), seen as discoloration of the returned devices; particularly the uhmwpe x3 liner.The analysis conducted did not find material non-conformances, nor indications of manufacturing defects.Dimensional and functional inspection not performed as device was returned in damage condition.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: the complaint databases show there been no other events for the reported lot.Similar events have occurred for the catalog number and product family.These events were determined to be associated with ra 2012-067.Clinical review ; a review of the provided medical records stated that - i cannot confirm that this event took place since i was not able to see any documentation other than a letter.No operation report and no xrays were provided.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of poly wear are multifactorial including surgical technique factors, patient factors such as activity level and bmi, and implant factors.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 abnormal ion level and corrosion is considered to be under the scope of this recall.No further investigation is required.

Event Description

It has been reported - the patient who underwent right hip replacement surgery in december 2010.Consultation in early 2020 for painful symptoms.The polyethylene component of her prosthesis was found to be very worn, with a very probable risk of metallosis, which could be the cause of her pain.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 11108543
• MDR Text Key: 224795871
• Report Number: 0002249697-2021-00013
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 4845-4-103
• Device Lot Number: G2044440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2008
• 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
• Patient Weight: 77 KG