MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BIPOLAR/UNIPOLAR TRIAL 51MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 1150-2351

Device Problems Break (1069); Degraded (1153); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Performing hemiarthroplasty on left hip while doing surgery uht trials broke (thread broke).No patient adverse consequence.

Manufacturer Narrative

Reported event: an event regarding damage involving a bipolar/unipolar trial 51mm was reported.The event was confirmed.Method & results: device evaluation and results: ¿damage was observed on the threads of the handle studs, handle shaft, and trial.The damages observed were consistent with in-service use and contact against a hard object.No material or manufacturing defects were observed on the surfaces examined.¿ medical records received and evaluation: not performed as medical records were received for review with a clinical consultant.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that damage to the trial head handle was caused by in-service use and contact against a hard object.No material or manufacturing defects were observed on the surfaces examined.

Event Description

Performing hemiarthroplasty on left hip while doing surgery uht trials broke (thread broke).No patient adverse consequence.

• Brand Name: BIPOLAR/UNIPOLAR TRIAL 51MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER SUZHIOU; no. 18 wuxiang, epz zone a; 200 suhong road, sip; suzhou 21502 1; CN 215021
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5611764
• MDR Text Key: 44512611
• Report Number: 0002249697-2016-01366
• Device Sequence Number: 1
• Product Code: MAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1150-2351
• Device Lot Number: 15009101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR