MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-501

Device Problems Product Quality Problem (1506); Defective Component (2292); 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 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the item had a misshapen leg which buckled and was unable to use.

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 2 lugs on the returned spigot are bent.Marks and impacts of the instrument are clearly visible on each lug; on the side of the lug but also on the bottom of the lug.The position of these marks is relevant with the use of the instrument.Medical records received and evaluation: not performed as medical records were not received for evaluation.No adverse consequences to the patient were reported.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 the item had a misshapen leg which buckled and was unable to use.

• Brand Name: EXETER V40 STEM 50MM NO 1
• 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: 5741133
• MDR Text Key: 47923111
• Report Number: 0002249697-2016-02025
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 0580-1-501
• Device Lot Number: G5884496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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