MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-440

Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311); Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Hospital contacted me to say when they opened this stem, the spigot protector was damaged and they were not able to load the stem onto the stem introducer.Another stem was opened and used.

Manufacturer Narrative

An event regarding a damaged spigot protector involving an exeter stem was reported.The event was confirmed.Method & results: -device evaluation and results: evaluation by the supplier confirmed that one lug of the spigot is bent.-medical records received and evaluation: not performed as medical records were not received for evaluation.-device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: a review of the complaint history database shows that there have been no similar events for the reported lot.Conclusions: the investigation concluded that the root cause of this event was due to a manufacturing issue with the spigot supplier.A review by supplier quality confirms the event is within the scope of capa.

Event Description

Hospital contacted me to say when they opened this stem, the spigot protector was damaged and they were not able to load the stem onto the stem introducer.Another stem was opened and used.

• Brand Name: EXETER V40 STEM 44MM NO 0
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5197251
• MDR Text Key: 30585865
• Report Number: 0002249697-2015-03615
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/06/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 0580-1-440
• Device Lot Number: G5660491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 11/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• 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