MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX ABC CE MARK 1 PCK; BONE CEMENT

Catalog Number 61969001

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

The distributor reported a report from it's customer : "during the placement of a total reverse shoulder prosthetic , in order to place the humeral stem we used the preparation of an antibiotic simplex® cement reference: (b)(4) lot number: bab003 expiration date: 31/10/2021.This cement was prepared by the sales rep of tornier (laboratory supplying the prosthetic).5 minutes after preparation, the surgeon took a small amount of cement, which was still very liquid (glued to the gloves), and placed it in the humeral shaft in order to slide the humeral stem in.A little cement had crept onto the humeral capsule and we tried to remove it for a few minutes.When we tried to insert the humeral stem, it turned out that the cement in the humeral shaft was set, whereas in the cup and on the operating table it was still soft and not heating up.The surgeon tried to make a hole in the cement, but it was really hard so it was impossible to do anything.The cement started to harden on the table when the surgeon decided to finish the operation without placing the humeral stem.".

Event Description

The distributor reported a report from it's customer : "during the placement of a total reverse shoulder prosthetic , in order to place the humeral stem we used the preparation of an antibiotic simplex® cement reference: 6198-9-001 lot number: bab003 expiration date: 31/10/2021.This cement was prepared by the sales rep of tornier (laboratory supplying the prosthetic).5 minutes after preparation, the surgeon took a small amount of cement, which was still very liquid (glued to the gloves), and placed it in the humeral shaft in order to slide the humeral stem in.A little cement had crept onto the humeral capsule and we tried to remove it for a few minutes.When we tried to insert the humeral stem, it turned out that the cement in the humeral shaft was set, whereas in the cup and on the operating table it was still soft and not heating up.The surgeon tried to make a hole in the cement, but it was really hard so it was impossible to do anything.The cement started to harden on the table when the surgeon decided to finish the operation without placing the humeral stem.".

Manufacturer Narrative

Reported event: an event regarding setting time involving a simplex cement mix was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection was performed on three of the retain samples of the reported lot while mixing the cement product.No unusual characteristics were observed during the mixing.It was also stated that the cement was seen to have a homogeneous appearance.Refer to attached laboratory results in communications tab.Functional testing was performed on three of the retain samples of the reported lot to verify the doughing time, working time and setting time of the product.The attached laboratory report show that the samples met the required specification for the test.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate ten-packs were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that during the placement of a total reverse shoulder prosthetic, the setting time issue was noticed.It was reported that the surgeon took a small amount of cement, which was still very liquid (glued to the gloves), and placed it in the humeral shaft in order to slide the humeral stem in.This practice did not follow ifu instructions in 0700-7-011 rev aa, "[.] for manual administration continue stirring until a dough-like mass is formed that does not stick to the surgical gloves of the operator.The dough-like mass is then ready for manipulation.The mixing and manipulation process should be at least 4 minutes in duration.The mixing and kneading time required to obtain a product of proper consistency for application to the bone is altered by the room temperature and humidity.The mixed and kneaded product is then ready to be applied to the bone manually.[.] after application of the product, position of the prosthesis must be maintained securely without movement until the cement is hard and the prostheseis is firmly fixed in position.Excess cement must be removed before it is totally hardened.[.]".Thus there seems to be a user error in place.The exact cause of the event could not be determined because insufficient information was provided.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIMPLEX ABC CE MARK 1 PCK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12057340
• MDR Text Key: 258208629
• Report Number: 0002249697-2021-01073
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 61969001
• Device Lot Number: BAB003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization