MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-352

Device Problems Fracture (1260); Material Fragmentation (1261)

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

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Event Description

The surgeon was in the process of cementing an exeter stem (ref: (b)(4)) (lot: g6017093) during an exeter unitrax case.During cementing clean up, he identified a small piece of plastic in the cement run off.The piece of plastic was identified to be one of the wings off the centraliser on the exeter stem and is shown in photo.To the best of my knowledge the centraliser and stem were inserted as per the surgical technique and did not receive any blows or impacts prior to insertion.The case proceeded as normal with no other events.

Manufacturer Narrative

An event regarding a crack/fracture issue involving a centraliser for an exeter stem was reported.The event was not confirmed.Method & results: - device evaluation and results: the device in this case was implanted but a photograph was provided by the surgeon.This photograph seemed to show one of the winged pieces of the centralizer which had broken off.No other information could be obtained from the photograph provided and the broken piece was not returned dimensional and functional inspection was not performed as no devices were returned.-medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including return of device are needed to complete the investigation for determining root cause.If further information becomes available this investigation will be re-opened.

Event Description

The surgeon was in the process of cementing an exeter stem (ref: 0580-1-352) (lot: g6017093) during an exeter unitrax case.During cementing clean up, he identified a small piece of plastic in the cement run off.The piece of plastic was identified to be one of the wings off the centraliser on the exeter stem and is shown in photo.To the best of my knowledge the centraliser and stem were inserted as per the surgical technique and did not receive any blows or impacts prior to insertion.The case proceeded as normal with no other events.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• 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-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6165715
• MDR Text Key: 62614310
• Report Number: 0002249697-2016-03882
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K121308
• 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: 03/29/2017

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: 06/30/2021
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G6017093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• 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: 84 YR