MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK HYDROSET INJECTABLE CEMENT KIT 5CC; IMPLANT

Catalog Number 397005

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device discarded at hospital.

Event Description

A company representative reported that during a mpj revision surgery, the doctor resected bad bone and wanted to use hydroset as bone void filler.The hydroset was mixed correctly but never set up or hardened.It was very watery and over 12 mins after implanting it began to crumble when slightly touched.Subsequently, no hardware could be put through the hyrdoset.The first box of hydroset used was taken out of the patient and the next box opened.The same issues happened with the second box.Both boxes were not expired.

Manufacturer Narrative

The reported event could not be confirmed because the complained devices were not returned.The investigation conducted is based on the test of the retain samples and the reviews of the batch manufacturing records (bmr).The devices were manufactured by stryker (b)(4).So the complaint information was forwarded to the manufacturing facility.Final functional testing was performed prior to releasing batches (b)(4), all testing was within specification and met the functional testing acceptance criteria.The reviews of the bmr were completed and no discrepancies were recorded.It has been confirmed that the products and their components (liquid and powder components) were manufactured per validated conditions.Both retain samples from final lots (b)(4) were tested using the hydroset wet field set penetration test.The tests were passed.Based on investigation and statistical evaluation there is no indication for any systematic design, material or manufacturing related issue.The complaint is added to the complaint trend.

Event Description

A company representative reported that during a mpj revision surgery, the doctor resected bad bone and wanted to use hydroset as bone void filler.The hydroset was mixed correctly but never set up or hardened.It was very watery and over 12 mins after implanting it began to crumble when slightly touched.Subsequently, no hardware could be put through the hyrdoset.The first box of hydroset used was taken out of the patient and the next box opened.The same issues happened with the second box.Both boxes were not expired.

• Brand Name: HYDROSET INJECTABLE CEMENT KIT 5CC
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick D-791 11
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: jonathan schell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5216909
• MDR Text Key: 30991410
• Report Number: 0008010177-2015-00297
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397005
• Device Lot Number: T75S9IC02059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 90 YR