MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURACON CNSTR TIB INS SM 13MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6642-9-613
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
When completed, the evaluation summary will be submitted in a supplemental report.Not returned to manufacturer.
Event or Problem Description
I was notified on monday the (b)(6) by one of our local doctors that he needed duracon cr inserts available for a poly swap on the (b)(6).Due to the availability we only received duracon "constrained" insert implants.Once i was for certain the ap lipped weren't available, i then contacted a marketing manager at corporate to inquire about what the "constrained" option meant.She proceeded to tell me this was a deep dish poly versus the ap lipped.As we proceeded with the case, he removed the old poly, and we trialed with a condylar trial and asked me to open the small 13mm implant (6642-9-613).The doctor was unable to make it sit down and unfortunately the insert hit the floor.We then proceeded to the 16mm insert (6642-9-616).The doctor again was having problems with it locking into the baseplate.We inspected the poly and realized this particular implant was designed for a pca baseplate.Due to the fact the box simply read duracon as well the information marketing gave me i was unable to prevent this occurrence.Update: rep reported that the first device "popped out" of patient and hit the floor of the operating room.A surgical delay of approximately 20 minutes was reported overall with use of tourniquet (total tourniquet time currently unknown).Surgeon decided to physically alter the 16mm insert and cement it in, primarily due to the patient's age at the time of event ((b)(6)).Rep did notify surgeon that this was an off-label use prior to alteration.
Event or Problem Description
I was notified on monday the 14th of may by one of our local doctors that he needed duracon cr inserts available for a poly swap on (b)(6).Due to the availability we only received duracon "constrained" insert implants.Once i was for certain the ap lipped weren't available, i then contacted a marketing manager at corporate to inquire about what the "constrained" option meant.She proceeded to tell me this was a deep dish poly versus the ap lipped.As we proceeded with the case, he removed the old poly, and we trialed with a condylar trial and asked me to open the small 13mm implant (6642-9-613).The doctor was unable to make it sit down and unfortunately the insert hit the floor.We then proceeded to the 16mm insert (6642-9-616).The doctor again was having problems with it locking into the baseplate.We inspected the poly and realized this particular implant was designed for a pca baseplate.Due to the fact the box simply read duracon as well the information marketing gave me i was unable to prevent this occurrence.Update: rep reported that the first device "popped out" of patient and hit the floor of the operating room a surgical delay of approximately 20 minutes was reported overall with use of tourniquet (total tourniquet time currently unknown).Surgeon decided to physically alter the 16mm insert and cement it in, primarily due to the patient's age at the time of event (80 years).Rep did notify surgeon that this was an off-label use prior to alteration.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving a duracon constrained insert was reported.The event was confirmed by labelling review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: not performed as medical records were not provided for review.Product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation confirmed the alleged event of seating/locking issues because the incorrect insert was being used.The user guide did not provide sufficient information for determining the appropriate component for revision.The duracon constrained insert is meant to be assembled with the pca system and the duracon a/p/ lipped insert is meant for the duracon system.The constrained liner would not have fit the baseplate as they are not designed to be assembled together.The user guide has since been updated to provide additional catalog numbers to ensure the appropriate insert is identified.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: DURACON CNSTR TIB INS SM 13MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7598178
• Report Number: 0002249697-2018-01804
• Device Sequence Number: 1277992
• Product Code: JDI
• UDI-Device Identifier: 04546540319364
• UDI-Public: 04546540319364
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 6642-9-613
• Device Lot Number: 45896401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR