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

Catalog Number 4845-4-203

Device Problems Mechanical Problem (1384); Device-Device Incompatibility (2919)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported that the patient is asymptomatic.Update (b)(6) 2023 wg: this pi is for the revision on (b)(6) 2023.It was reported that the patient's left hip was revised due to recurrent dislocations.An abgii modular stem (implanted 01/november/2011), femoral head (implant date unknown), and poly liner implanted (b)(6) 2023 were revised to a competitor stem and head, with a stryker poly liner.Rep will provide all images and documentation available to her from the hospital and surgeon.

Manufacturer Narrative

The complaint databases show there have been 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.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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.

Manufacturer Narrative

Reported event: an event regarding dislocation involving an abgii stem was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned; however, a photograph was provided for review.The photograph shows a modular stem assembly covered in blood.No obvious damage can be seen in the photograph.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: very minimal medical information was provided for review.It appears a woman had a tha with a modular abg stem in 2011.No data was provided for the next 12 years.Apparently, a prior revision had been performed.Reasons for the revision were not provided, but one note indicted that there was osteolysis around the cup.The patent went on to develop recurrent instability instability and apparently underwent a second revision, possibly just a polyethylene exchange, but the procedure was not documented.Event confirmation: a da tha in 2011 can be confirmed.The revision procedures cannot be confirmed without additional medical information.Dislocations were documented only by a medical history.Root cause: the root cause of the first revision cannot be determined.The root cause of the second revision, if documented, would be recurrent instability." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to recurrent dislocations.A review of the provided medical information by a clinical consultant indicated: "event confirmation: a da tha in 2011 can be confirmed.The revision procedures cannot be confirmed without additional medical information.Dislocations were documented only by a medical history.Root cause: the root cause of the first revision cannot be determined.The root cause of the second revision, if documented, would be recurrent instability." no further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient is asymptomatic.Update 01/september/2023 wg: this pi is for the revision on (b)(6) 2023.It was reported that the patient's left hip was revised due to recurrent dislocations.An abgii modular stem (implanted (b)(6) 2011), femoral head (implant date unknown), and poly liner (implanted (b)(6) 2023) were revised to a competitor stem and head, with a stryker poly liner.Rep will provide all images and documentation available to her from the hospital and surgeon.

• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17824819
• MDR Text Key: 324354992
• Report Number: 0002249697-2023-01080
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 4845-4-203
• Device Lot Number: G2989350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2010
• 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): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 113 KG