MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HUDSON TO STRYKER ADAPTOR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2102-0003

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When reaming the acetabulum, the rotation of the reamer was shaking.Connection between the attachment and the distal part of the reamer handle was unstable.

Manufacturer Narrative

An event regarding assembly issue involving a hudson to stryker adaptor was reported.The event was not confirmed.Method & results: device evaluation and results: the device was returned in used condition with damage consistent with in-use service.The device was inspected with the go/no gage as per the igs and found it to be functionally acceptable.Medical records received and evaluation: not performed as medical records were not provided for review.Device 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 event nor the root cause could be determined as the event could not be replicated.The device was found be fully functional and passed the igs requirement with the go/no gages.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

When reaming the acetabulum, the rotation of the reamer was shaking.Connection between the attachment and the distal part of the reamer handle was unstable.

• Brand Name: HUDSON TO STRYKER ADAPTOR
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6875974
• MDR Text Key: 86606854
• Report Number: 0002249697-2017-02825
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K161569
• 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: 01/12/2018

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 Catalogue Number: 2102-0003
• Device Lot Number: S304588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/1998
• 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