MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 2101-0200

Device Problems Break (1069); Crack (1135); Split (2537); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 09/15/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Cup impactor broke at shaft/handle.White plastic handle split in three places.At the same timetritanium shell penetrated through medial wall of acetabulum.

Manufacturer Narrative

An event regarding fractured handle involving a universal impactor/positioner was reported.The event was confirmed.Method & results: -device evaluation and results: the returned device was in used condition.The visual inspection confirmed the fractured handle.-medical records received and evaluation: no medical records were received.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other similar events reported for this lot.Conclusions: the investigation concluded the handle was cracked due to a design issue.A capa and ecn were issued.An ecn was initiated on apr-2008 for the modification of the radel handle, internal shaft geometry, and strike plate of the universal impactor/postioner, catalog: 2101-0200.The capa was closed and the ecn implemented on 27-oct-2010.

Event Description

Cup impactor broke at shaft/handle.White plastic handle split in three places.At the same timetritanium shell penetrated through medial wall of acetabulum.

Manufacturer Narrative

A second supplemental report is being submitted on 5/1/2017 to correct the lot code and add the corresponding manufacturing date.

Event Description

Cup impactor broke at shaft/handle.White plastic handle split in three places.At the same time tritanium shell penetrated through medial wall of acetabulum.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5145580
• MDR Text Key: 28078113
• Report Number: 0002249697-2015-03340
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2101-0200
• Device Lot Number: BWWAC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2003
• 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: 60 YR
• Patient Weight: 106