MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACETABULAR REAMER 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2102-0458

Device Problem Dull, Blunt

Event Date 12/20/2017

Event Type  Malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Reamer baskets are dull. Surgeon had difficulty resecting bone. Total hip arthroplasty case delayed for 5 minutes.

• Brand Name: ACETABULAR REAMER 58MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah , NJ 07430 ; 2018315000
• MDR Report Key: 7202446
• Report Number: 0002249697-2018-00192
• Device Sequence Number: 1
• Product Code: LPH
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL,OTHER

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/17/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 2102-0458
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 01/17/2018 Patient Sequence Number: 1