MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-444

Device Problems Bent (1059); Material Deformation (2976)

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

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that when the exeter stem was opened, the spigot protector appeared to be deformed.A new device was on hand to complete the case.

Manufacturer Narrative

An event regarding a damage issue involving a spigot protector for a exeter stem was reported.The event was confirmed.Device evaluation and results: a visual inspection completed by the supplier indicated: the yellow spigot shows a bent lug.We can see high material deformation on the bent lug, exactly located on the area where the stem inserter has to connect with the spigot.There is also deformation on the second lug.There are also marks of use with the instrument.Medical records received and evaluation: not performed as no adverse consequences to the patient were noted and no medical records were provided.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.Conclusions: the investigation performed by the supplier on the returned part concluded "concluded that bent spigots are not due to manufacturing defect.The returned spigot shows bent lugs and visual marks of material bulge that are consistent with a misuse of the device".No further investigation is required at this time if further information becomes available this investigation will be re-opened.

Event Description

The surgeon noticed that the spigot protector was damage immediately when the exeter stem was opened; the spigot protector appeared to be deformed.A new device was on hand to complete the case.

• Brand Name: EXETER V40 STEM 44MM NO 4
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6655485
• MDR Text Key: 78143470
• Report Number: 0002249697-2017-01953
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0580-1-444
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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