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

Catalog Number 4845-4-206

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 06/03/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Peri prosthetic fracture around an abg modular stem.

Manufacturer Narrative

An event regarding periprosthetic fracture involving a abg stem was reported.The event was confirmed.Device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was performed and concluded: "this pi case is not device-related.A traumatic fall of the patient at 6-years post arthroplasty caused a periprosthetic fracture with subsequent subsidence of the stem requiring revision with fracture stabilisation about which no details are available" device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.A medical review was performed and diagnosed that "a traumatic fall of the patient at 6-years post arthroplasty caused a periprosthetic fracture with subsequent subsidence of the stem requiring revision with fracture stabilisation about which no details are available" there was no evidence to indicate this was device related.No further investigation is required.If further relevant information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Peri prosthetic fracture around an abg modular stem.

• Brand Name: ABGII. MODULAR STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6675864
• MDR Text Key: 78653716
• Report Number: 0002249697-2017-02061
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Catalogue Number: 4845-4-206
• Device Lot Number: G3003756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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: 77 YR
• Patient Weight: 90