MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40(TM). SHORT FEMORAL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-044
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
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.Device not returned.
Event or Problem Description
The surgeon reported that as he was undertaking a cement in cement revision of an exeter stem (g1867666) and he attempted to put a short stem exeter (g7245275) into the femur after removing the original stem.The surgeon reported that the new stem (g7245275) would not fit the hole left after explantation of the primary device.The stem was removed due to a poor fit using a broach handle and could then no longer be used for this patient.The surgeon reamed (and also used oscar to remove some additional cement mantle) and then attempted implantation with a second short stem exeter (g7152308).This was successful but the surgeon reported that there were differences distally between the old and two new stems.The surgeon also noted that when he used a trial stem (g3122879) this was also a tight fit compared to the original.The case was completed successfully.Primary surgery was done in 2007.Rep has confirmed that surgical delay was 1-1.5hours.
Additional Manufacturer Narrative
An event regarding size/fit involving an exeter stem was reported.The event was not confirmed.Conclusions: the event could not be confirmed because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device & surgical 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 surgeon reported that as he was undertaking a cement in cement revision of an exeter stem ((b)(4)) and he attempted to put a short stem exeter ((b)(4)) into the femur after removing the original stem.The surgeon reported that the new stem ((b)(4)) would not fit the hole left after explantation of the primary device.The stem was removed due to a poor fit using a broach handle and could then no longer be used for this patient.The surgeon reamed (and also used oscar to remove some additional cement mantle) and then attempted implantation with a second short stem exeter ((b)(4)).This was successful but the surgeon reported that there were differences distally between the old and two new stems.The surgeon also noted that when he used a trial stem ((b)(4)) this was also a tight fit compared to the original.The case was completed successfully.Primary surgery was done in 2007.Rep has confirmed that surgical delay was 1-1.5hours.

• Brand Name: EXETER V40(TM). SHORT FEMORAL
• 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: 7429544
• Report Number: 0002249697-2018-01128
• Device Sequence Number: 13992333
• Product Code: LPH
• UDI-Device Identifier: 04546540509048
• UDI-Public: 04546540509048
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: 04/30/2023
• Device Catalogue Number: 0580-1-044
• Device Lot Number: G7245275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 06/15/2018
• 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