MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-442

Device Problems Product Quality Problem (1506); Fitting Problem (2183); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)

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

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The surgeon reported on (b)(6) 2015 that the spigot protector looks twisted on one side and does not fit onto the introducer.This surgeon reported that he noticed this when the device was opened and he tried to fit it onto the introducer.Another device was on hand and the case was completed successfully.

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: the device was not returned, however an image was provided.It was 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 that the event is within the scope of capa.

Event Description

The sales representative reported that this was originally notified last week by stores, but at that time, the person handling theatre supplies reported that a replacement was needed because the surgeon had broken the protector.At that time there was no alleged deficiency in relation to this device and as such a per was not raised.However, while the representative was in conversation with the surgeon on (b)(6) 2015, he clarified that he had not broken the device but that he had noticed the twisted spigot as it was taken out of the wrapping.

• Brand Name: EXETER V40 STEM 44MM NO 2
• 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: 5216489
• MDR Text Key: 31209418
• Report Number: 0002249697-2015-03696
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

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: 01/31/2020
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G5599494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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