MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CURVED CUP IMPACTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 1440-2010

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Instrument broke during total right hip surgery.No impact to patient.

Manufacturer Narrative

An event regarding a fractured da instrument impaction handle was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection was performed on the returned device and concluded "examination of device by a material analyst engineer indicated that the fracture is consistent with torsional overload." condition".Medical records received and evaluation: not performed as no adverse consequences to the patient were noted.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 3 other events for the lot referenced.Conclusions: the investigation concluded that the device fractured due to an overload condition.

Event Description

Instrument broke during total right hip surgery.No impact to patient.

• Brand Name: CURVED CUP IMPACTOR
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6213608
• MDR Text Key: 63772456
• Report Number: 0002249697-2016-04055
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1440-2010
• Device Lot Number: DC239163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other