MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	0580-1-501
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that they opened an exeter stem and noticed that the lug had broken off the spiggot protector.A new implant was used to complete the case.
Event or Problem Description
The customer reported that they opened an exeter stem and noticed that the lug had broken off the spiggot protector.A new implant was used to complete the case.
Additional Manufacturer Narrative
An event regarding damage involving an exeter spigot protector was reported.The event was confirmed.A visual inspection of the returned device by the supplier noted "the pictures show a broken lug and visual marks that are consistent with a misuse of the device".No medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The investigation concluded that damage was consistent with a misuse of the device.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: EXETER V40 STEM 50MM NO 1
• Common Device Name: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7861833
• Report Number: 0002249697-2018-02815
• Device Sequence Number: 1986864
• Product Code: JDI
• UDI-Device Identifier: 04546540153364
• UDI-Public: 04546540153364
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• 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): 11/29/2018

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: 10/30/2022
• Device Catalogue Number: 0580-1-501
• Device Lot Number: G7202047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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