MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER STEM #2 50MM OFFSET; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 0570-2-001

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

It was reported that doctor recognized that stem had broken on x-ray pre operation.Was revised for broken implant.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed for crack/fracture following visual inspection of images provided.Method & results: device evaluation and results: visual inspection: the device was not returned however images of the device were provided.The images showed the device fractured in the neck region of the stem.Some debris was also observed on the stem.Dimensional and functional inspection was not performed as the device was not returned for evaluation.Medical records received and evaluation: insufficient information was received for review with the clinical consultant.Device history review : not performed as device lot number is unknown.Complaint history review: not performed as device lot number is unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device lot details, return of device, 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.Product surveillance will continue to monitor for trends.

Event Description

It was reported that doctor recognized that stem had broken on x-ray pre operation.Was revised for broken implant.

• Brand Name: EXETER STEM #2 50MM OFFSET
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5375186
• MDR Text Key: 36204915
• Report Number: 0002249697-2016-00118
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K891454
• 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: 12/21/2015

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: 0570-2-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• 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
• Patient Age: 72 YR
• Patient Weight: 90