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

Catalog Number 4845-4-104

Device Problem Fracture (1260)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 06/28/2021

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

The customer reported that : "fracture of the femoral implant at the stem/neck junction on a modular stem modular abg stem n4 right.".

Manufacturer Narrative

An event regarding crack/fracture involving an abgii stem 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 a portion of the device fractured off at the junction where the device mates with the modular neck.Material analysis: a material analysis was performed and concluded the following: "a fatigue-related fracture imitated on the lateral edge of the abgii modular stem.It propagated medially until overload occurred resulting in one small piece becoming completely separated.No material defects or non-conformances were found, nor any manufacturing defects seen on any of the surfaces analyzed herein." clinician review: a review of the provided medical records by a clinical consultant indicated: "i can confirm that the event occurred since it is reported by a stryker representative.I do not have specific information regarding the operation report since it has no name on it or other demographics.Regarding the possible root cause of this event, i cannot determine this for certain.Fracture of a modular femoral neck is well documented, and causes can be multi factorial including patient demographics, activity level and surgical technique.I certify that i have completed the medical risk assessment to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no 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 fracture of the stem/neck.Visual inspection of the returned device indicated that a portion of the device fractured off at the junction where the device mates with the modular neck.A material analysis was performed and concluded the following: "a fatigue-related fracture imitated on the lateral edge of the abgii modular stem.It propagated medially until overload occurred resulting in one small piece becoming completely separated.No material defects or non-conformances were found, nor any manufacturing defects seen on any of the surfaces analyzed herein." 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 customer reported that: "fracture of the femoral implant at the stem/neck junction on a modular stem modular abg stem n4 right.".

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12208875
• MDR Text Key: 262863159
• Report Number: 0002249697-2021-01255
• 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: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• 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: 4845-4-104
• Device Lot Number: G2042083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG