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

Catalog Number 4845-4-416

Device Problem Fracture (1260)

Patient Problem Ambulation Difficulties (2544)

Event Date 05/15/2021

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.Voluntary recall ra (b)(4) was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices.Although the reported device is considered to be under the scope of this recall, the reported failure mode is not.Device not returned.

Event Description

The distributor reported that: "spontaneous fracture of a hip prosthesis at home.Functional impotence.Indication for removal and replacement of a left thp performed on (b)(6) 2020.".

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an abgii neck was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the base of the neck is fractured.The fractured piece was not returned for evaluation.The ceramic head remains securely attached to the trunnion of the neck.Material analysis: a material analysis was performed and indicated the following: "the fracture morphology was consistent with a fatigue fracture.Cyclic stresses on the assembly caused by repetitive motions initiated a lateral surface fracture on both the abgii modular short neck that was inserted into the ceramic head, and the femoral insert abgii modular stem.The fractures propagated medially until becoming unstable.The modular short neck fractured in overload which created a large impulse stress on the modular stem¿s medial wall, which then fractured, resulting in a small section separating entirely.No material non-conformances, nor manufacturing defects were found on any of the surfaces investigated here." -clinician review: no medical records were received for review with a clinical consultant.-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.Visual inspection of the returned device indicated that the base of the neck is fractured.The fractured piece was not returned for evaluation.The ceramic head remains securely attached to the trunnion of the neck.A material analysis was performed and indicated the following: "the fracture morphology was consistent with a fatigue fracture.Cyclic stresses on the assembly caused by repetitive motions initiated a lateral surface fracture on both the abgii modular short neck that was inserted into the ceramic head, and the femoral insert abgii modular stem.The fractures propagated medially until becoming unstable.The modular short neck fractured in overload which created a large impulse stress on the modular stem¿s medial wall, which then fractured, resulting in a small section separating entirely.No material non-conformances, nor manufacturing defects were found on any of the surfaces investigated here." it was also reported that the patient has a history of obesity.Per the ifu, the heavier the patient, the greater the load on the prosthesis.This patient factor may have been a contributing factor to the device failure.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The distributor reported that: "spontaneous fracture of a hip prosthesis at home.Functional impotence.Indication for removal and replacement of a left thp performed on (b)(6) 2020.".

• Brand Name: ABGII MODULAR LONG 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12067313
• MDR Text Key: 258364003
• Report Number: 0002249697-2021-01084
• 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,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 4845-4-416
• Device Lot Number: G2864014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2009
• 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: Male
• Patient Weight: 135 KG