MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURACON CS TIBIA INSERT SM 13; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 67424113

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was retained by the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported that surgeon did a poly swap on patients' left knee due to poly failure.Intra operatively when surgeon removed the poly, surgeon noticed the baseplate was cracked but surgeon left baseplate implanted and exchanged the poly only.

Manufacturer Narrative

An event regarding wear involving a duracon insert was reported.The event was not confirmed.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: post right knee revision follow-up on (b)(6) 2015, documents adequate healing and good recovery of functionality in the revised right knee although now also instability in the left knee was noted that would require revision surgery, to be planned in the near future.No actual information is available for this revision surgery other than listed in the pi intake about liner exchange and crack in the retained baseplate.Gross instability was observed on physical examination prior to revision with on x-ray near metal-metal contact.No factual information is available to further assess this case.It should be noted that this patient had gross overweight.No exact values were listed but it was reported the patient had some 100-lbs excess weight and should reduce weight.Still, such excess weight might aggravate the effects of the instability but not likely cause it.It would remain a secondary factor and not a principal factor.More information would be required to solve this case, preferably x-rays as well as more clinical information.Device history review: the reported device was accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as product return, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product.

Event Description

It was reported that surgeon did a poly swap on patients' left knee due to poly failure.Intra operatively when surgeon removed the poly, surgeon noticed the baseplate was cracked but surgeon left baseplate implanted and exchanged the poly only.

• Brand Name: DURACON CS TIBIA INSERT SM 13
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5263681
• MDR Text Key: 32597736
• Report Number: 0002249697-2015-04129
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032163
• 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: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Catalogue Number: 67424113
• Device Lot Number: LPTB324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2005
• 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): Required Intervention
• Patient Age: 76 YR