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
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2017
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 available.
Event or Problem Description
The customer reported that the spigot of the exeter hip would not fit onto the exeter introducer.The surgeon removed the plastic part and proceeded to introduce the exeter stem by hand.There was no delay to surgery but it did mean that the standard instrumentation could not be used.
Additional Manufacturer Narrative
An event regarding size/fit issue involving an exeter stem spigot protector was reported.The event was not confirmed.Device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.A review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review confirmed that there have been no other similar events for the reported lot.It was reported that during surgery, the spigot of the exeter hip would not fit onto the exeter introducer.The surgeon removed the plastic part and proceeded to introduce the exeter stem by hand.There was no delay to surgery but it did mean that the standard instrumentation could not be used.The event could not be confirmed nor the root cause determined since the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, images of the reported issue, pre- and post-op xrays, operative reports, & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
The customer reported that the spigot of the exeter hip would not fit onto the exeter introducer.The surgeon removed the plastic part and proceeded to introduce the exeter stem by hand.There was no delay to surgery but it did mean that the standard instrumentation could not be used.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6996187
• Report Number: 0002249697-2017-03177
• Device Sequence Number: 11014421
• Product Code: LPH
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G7103524A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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