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

Catalog Number 4845-4-417

Device Problems Material Erosion (1214); Device-Device Incompatibility (2919)

Patient Problems Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414); Ambulation Difficulties (2544)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.

Event Description

Revision surgery.Following this second episode of dislocation, an assessment was carried out.A ct scan of the left hip was performed on (b)(6) 2018, which revealed a major peri-prosthetic pseudotumoral mass invading the pelvis and the muscles surrounding the psoas, particularly the psoas, with disseminated bone erosion.(b)(6) also reported that he had had a feeling of mass above the left iliac crest for at least 8 months which was not correctly relieved by paracetamol.Finally, we note several cobaltemia dosages: 5.22 ¿g on (b)(6) 2013.4.10 ¿g on (b)(6) 2014.5.45 ¿g on (b)(6) 2014.4.48 ¿g on (b)(6) 2016.3.23 ¿g on (b)(6) 2017.Finally, (b)(6) was hospitalized from (b)(6) 2019 for recovery.Complete left total hip replacement.This surgery was related to an inappropriate tissue reaction at the interface of the abg ii prosthesis.The operative count indicates an uncomplicated surgery on (b)(6) 2019.At discharge, the patient was on eliquis for one month.The patient was given the usual postural advice to avoid flexion and internal rotation on the first six weeks.The postoperative pictures of (b)(6) 2019 show a well oriented prosthesis, with collar, cement-free.(b)(6) does not have the pathology report.Nor does he have cobalt dosage in intra-articular fluid.A last cobalt assay was done on (b)(6) 2019 at 1.22 ¿g.Follow-up was then regular but no record of consultations is available.Various shots are presented on (b)(6) 2019 and (b)(6) 2019.These are stable.The orthopaedist has retained a consolidation on (b)(6) 2019.

Event Description

Revision surgery following this second episode of dislocation, an assessment was carried out.A ct scan of the left hip was performed on (b)(6) 2018, which revealed a major peri-prosthetic pseudotumoral mass invading the pelvis and the muscles surrounding the psoas, particularly the psoas, with disseminated bone erosion.Mr.Sot also reported that he had had a feeling of mass above the left iliac crest for at least 8 months which was not correctly relieved by paracetamol.Finally, we note several cobaltemia dosages: 5.22 g on (b)(6) 2013, 4.10 g on (b)(6) 2014, 5.45 g on (b)(6) 2014, 4.48 g on (b)(6) 2016, 3.23 g on (b)(6) 2017.Finally, mr.Sot was hospitalized from (b)(6) to (b)(6) 2019 for recovery.Complete left total hip replacement.This surgery was related to an inappropriate tissue reaction at the interface of the abg ii prosthesis.The operative count indicates an uncomplicated surgery on (b)(6) 2019.At discharge, the patient was on eliquis for one month.The patient was given the usual postural advice to avoid flexion and internal rotation on the first six weeks.The postoperative pictures of (b)(6) 2019 show a well oriented prosthesis, with collar, cement-free.Mr sot does not have the pathology report.Nor does he have cobalt dosage in intra-articular fluid.A last cobalt assay was done on (b)(6) 2019 at 1.22 g.Follow-up was then regular but no record of consultations is available.Various shots are presented on (b)(6) 2019 and (b)(6) 2019.These are stable.The orthopaedist has retained a consolidation on (b)(6) 2019.

Manufacturer Narrative

Reported event: an event regarding revision due to pseudotumoral mass involving a 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 found the devices in the reported lot were accepted into final stock with no reported discrepancies.Complaint history review: 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.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 revision due to pseudotumoral mass is considered to be under the scope of this recall.No further investigation is required.H3 other text : device not returned.

• Brand Name: ABGII MODULAR LONG NECK
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10007083
• MDR Text Key: 189499806
• Report Number: 0002249697-2020-00826
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 4845-4-417
• Device Lot Number: G2688071
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2089-2012
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 92