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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Per sales rep, the direct anterior cup impactor handle broke.It snapped right where handle meets the instrument.

Manufacturer Narrative

Corrected data: 3/31/2014.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 by the materials analysis engineer, this concluded "after examining the device, it was determined the curved cup impactor fractured due to an 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 complaints for this lot.All complaints are for impactor handle break.Conclusions: the investigation concluded that the device fractured due to an overload condition.

Event Description

Per sales rep, the direct anterior cup impactor handle broke.It snapped right where handle meets the instrument.

• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6103103
• MDR Text Key: 59974703
• Report Number: 0002249697-2016-03597
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• 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: 01/18/2017

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: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2014
• 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
• Patient Age: 57 YR