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 Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Exeter stem was opened and there was no pmma centralisers in the packaging.Surgeon requested for a second stem to be opened and he used the pmma centraliser from the second stem on the implant that was first opened.

Manufacturer Narrative

An event regarding missing centralizer involving an exeter stem was reported.The event was confirmed.Method and results: device evaluation and results: device evaluation was not performed as the device was not returned for evaluation.A dhr review confirms the correct packaging components were issued to the lot.Medical records received and evaluation: not performed as not medical records were not provided 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 reported events for the subject lot code.Conclusions: the investigation concluded that the root cause of this event was related to the supplier process.A review of the event by a supplier qe confirmed that this event is within the scope of a capa as it was manufactured prior to the implementation of the camera which is used to detect the presence of centralisers.

Event Description

Exeter stem was opened and there was no pmma centralisers in the packaging.Surgeon requested for a second stem to be opened and he used the pmma centraliser from the second stem on the implant that was first opened.Update: the sales rep indicated that the packaging for the two devices looked completely different they want to know why the packaging looks different and why 2 standard pmma plugs were not included.

• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5180433
• MDR Text Key: 30031358
• Report Number: 0002249697-2015-03459
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G3654142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• 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
• Patient Age: 83 YR
• Patient Weight: 84