MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HA STEM; HIP IMPLANT

Catalog Number UNK_REC

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 12/29/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that surgeon revised patient's left hip due to stem disassociated from the trunnion due to trunnion wear - revised to competitive product.

Manufacturer Narrative

Corrected data: the device was not returned for evaluation.An event regarding disassociation involving an unknown omnifit stem was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: the device was not returned however images of the device were provided.The image showed wear on the stem trunnion.Medical records received and evaluation: a review of the provided information by a clinical consultant concluded that : due to lack of information, the exact root cause of failure in 2015 with stem revision cannot be established although quite likely several procedure-related factors were the major and principal failure factors involved and not device-related factors.X-rays would be required to establish such a procedure-related root cause of failure with more certainty.Under the given conditions with very limited clinical information such a root cause nevertheless remains the most likely failure cause but cannot be proven with complete certainty based upon the available limited evidence.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of device, additional operative reports, xrays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.Not returned.

Event Description

It was reported that surgeon revised patient's left hip due to stem disassociated from the trunnion due to trunnion wear - revised to competitive product.

• Brand Name: UNKNOWN HA STEM
• Type of Device: HIP IMPLANT
• 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: 5391745
• MDR Text Key: 36884824
• Report Number: 0002249697-2016-00192
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2015
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention