MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CONSTRAINED ACETABULAR INSERTS; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number 2099-2250

Device Problems Break (1069); Device Abrasion From Instrument Or Another Object (1387); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown constrianed liner.When completed, the investigation results will be submitted in a supplemental report.

Event Description

During the revision, the surgeon tried to implant a constrained liner and broke the locking mechanism on the liner.

Manufacturer Narrative

An event regarding seating and locking issues involving a constrained acetabular inserts was reported.The event was confirmed.Method & results: device evaluation and results: the surface of the od and the locking wire were returned damaged, confirming the event.Medical records received and evaluation: not performed as patient factors 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 reported events for this lot id.Conclusions: the investigation concluded that damage is most likely caused by misaligning the liner with the shell during implantation.

Event Description

During the revision, the surgeon tried to implant a constrained liner and broke the locking mechanism on the liner.Update as per sales rep, doa: (b)(6) 2015: surgeon implanted a 50mm liner and than implanted the 22mm head on the stem and reduced it.He noticed the liner wasn't secure and kept popping out of the cup.That is also when he noticed the locking wire was broken.Surgeon than tried to use a 52mm liner but it didn't fit.He opted for a traditional 32mm liner with a hood and a 32mm head.There was no delay or surgery or adverse consequences.

• Brand Name: CONSTRAINED ACETABULAR INSERTS
• Type of Device: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5130092
• MDR Text Key: 27931604
• Report Number: 0002249697-2015-03273
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 2099-2250
• Device Lot Number: MNN1K7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2014
• 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: 92 YR