MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 502-03-50D

Device Problems Degraded (1153); Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

During total hip arthroplasty, a 50mm tritanium cluster shell was opened on the sterile field.The scrub tech tried to thread the direct anterior cup impactor bolt into the dome of the shell.The threads would not engage, and the surgeon made an attempt at it also and it failed to engage.He then took the bolt and threaded it into the dome on the outside of the shell and it engaged.He then stated " the threads are reversed in this shell, send it back" a new 50mm tritanium shell was opened and the threads engaged with no problem.

Manufacturer Narrative

An event regarding thread damage involving a tritanium shell was reported.The event was confirmed.Method & results: device evaluation and results: examination of the returned device with material analysis engineer indicated that the top thread is plastically deformed which would inhibit the insertion of the male threaded instrument.A dimensional inspection was performed to measure the thread using the thread gage ma-09434 and it failed the inspection as the thread is not accepting from inside.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: a functional and dimensional inspection was performed which confirmed the reported event.Also, a material analysis engineer indicated that the top thread is plastically deformed which would inhibit the insertion of the male threaded instrument.However, the root cause could not be confirmed.If additional information are received, this investigation will be reopened and re-evaluated.

Event Description

During total hip arthroplasty, a 50mm tritanium cluster shell was opened on the sterile field.The scrub tech tried to thread the direct anterior cup impactor bolt into the dome of the shell.The threads would not engage, and the surgeon made an attempt at it also and it failed to engage.He then took the bolt and threaded it into the dome on the outside of the shell and it engaged.He then stated " the threads are reversed in this shell, send it back" a new 50mm tritanium shell was opened and the threads engaged with no problem.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6087691
• MDR Text Key: 59843887
• Report Number: 0002249697-2016-03530
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• 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: 03/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 502-03-50D
• Device Lot Number: T5230A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• 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: 74 YR
• Patient Weight: 73