MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-352

Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976)

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

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that they opened up an exeter stem for the case and there was a deformed spigot.Update: the stem with the deformed spigot was not used during the case.Another stem was on hand.

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 returned spigot is received in the internal blister.The spigot is not in the right axis of the stem, and the spigot is not completely driven on the neck of the stem.With this position, it is not possible to package the stem in the internal blister (tyvek lid will be torn apart).White dust is present on the spigot and on the trunnion of the stem but it is still possible to rotate the spigot around the trunnion.On the returned spigot, it is observed that a one of the lug of the spigot is bent.On the body of the spigot, under the two lugs, we can see raw material bulge consistent with a contact with a stem introducer.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 to (b)(4).

Event Description

The customer reported that they opened up an exeter stem for the case and there was a deformed spigot.The stem with the deformed spigot was not used during the case.Another stem was on hand.The faulty stem & trunnion protector was noticed when the stem was opened onto sterile field and the staff attempted to load it onto stem introducer.

• Brand Name: EXETER V40 STEM 37.5MM 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5483205
• MDR Text Key: 40036127
• Report Number: 0002249697-2016-00692
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G5772527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• 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