MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 32MM/+5; IMPLANT

Catalog Number 06-3205

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

During a primary left hip surgery, surgeon implanted a eon stem.When surgeon went to put the 32mm +5 head on stem, the head did not fit - surgeon made 4 attempts to get head to fit on stem and then opened +7.5 head which fit on the stem.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

An event regarding difficulty seating a c-taper cocr lfit head onto an omnifit eon stem was reported.The event was not confirmed.Method & results: -device evaluation and results: the returned head was successfully assembled to an omnifit eon stem from finished goods.Therefore the event could not be replicated.-medical records received and evaluation: not performed as patient records did not contribute to the event.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events.Conclusions: the investigation concluded the returned c-taper cocr lfit head is fully functional.The exact cause of the event could not be determined because the associated stem was not returned for investigation.No further investigation for this event is possible at this time.

Event Description

During a primary left hip surgery, surgeon implanted a eon stem.When surgeon went to put the 32mm +5 head on stem, the head did not fit - surgeon made 4 attempts to get head to fit on stem and then opened +7.5 head which fit on the stem.

• Brand Name: C-TAPER COCR LFIT HEAD 32MM/+5
• Type of Device: IMPLANT
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4777606
• MDR Text Key: 5780905
• Report Number: 0002249697-2015-01596
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

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 Expiration Date: 05/31/2016
• Device Catalogue Number: 06-3205
• Device Lot Number: MKH72P
• Other Device ID Number: LOT CODE# MSHKJ12A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2011
• 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): Other
• Patient Age: 77 YR