MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-443
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
Surgeon was placing definitive exeter implant onto the stem introducer.I noticed he had placed the winged centraliser onto the stem for a small canal.We discussed his option to use the straight centraliser to use with alongside the small artisan plug.He acknowledged my suggestion but chose to go ahead with the winged centraliser.He then attached the implant onto the stem introducer and wrapped a pack over the end of the stem and placed it on the table still wrapped in the pack.He then picked up the stem, wrapped in the pack so that the tip was not visible and proceeded to insert the stem into the patient/cement.It was then noticed by the stryker representative that the centraliser was on the table behind some retractors.The rep brought this to the immediate attention of the surgeon to which he replied, ¿oh well, too late now¿.
Additional Manufacturer Narrative
An event regarding off label use involving an exeter stem was reported.Conclusion: a review of the exeter® v40® femoral stem using exeter broach, exeter-(b)(4) noted the following: the hollow centraliser must be used with the exeter stem because it provides a space below the stem tip, which prevents ¿end-bearing¿ of the stem and ensures that the proximal, expanded taper of the stem will engage properly in the cement mantle.Each exeter v40 stem is supplied with a winged and a straight-sided centraliser.Based on the provided information it has been determined that this event is associated with an off-label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Surgeon was placing definitive exeter implant onto the stem introducer.I noticed he had placed the winged centraliser onto the stem for a small canal.We discussed his option to use the straight centraliser to use with alongside the small artisan plug.He acknowledged my suggestion but chose to go ahead with the winged centraliser.He then attached the implant onto the stem introducer and wrapped a pack over the end of the stem and placed it on the table still wrapped in the pack.He then picked up the stem, wrapped in the pack so that the tip was not visible and proceeded to insert the stem into the patient/cement.It was then noticed by the stryker representative that the centraliser was on the table behind some retractors.The rep brought this to the immediate attention of the surgeon to which he replied, ¿oh well, too late now¿.

• Brand Name: EXETER V40 STEM 44MM NO 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8047657
• Report Number: 0002249697-2018-03650
• Device Sequence Number: 1188080
• Product Code: JDI
• UDI-Device Identifier: 04546540153326
• UDI-Public: 04546540153326
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 0580-1-443
• Device Lot Number: G7179410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other