MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-372

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the surgeon, one of the prongs on the spigot protector was bent when the prosthesis was unpacked.It was therefore not possible to attach it to the stem introducer, so the prosthesis was positioned by hand.There were no adverse consequences and it did not affect the outcomes the surgery.

Manufacturer Narrative

An event regarding a damage issue involving a spigot protector for a exeter stem was reported.The event was confirmed.Method & results: device evaluation and results: a visual inspection completed by the supplier indicated: "pictures of the spigot were received on november 27th 2017.It shows that the spigot is bent and damaged, with typical marks observed in previous similar complaints, consistent with a misuse of the device" medical records received and evaluation: not performed as no medical records were received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the investigation performed by the supplier on the returned part concluded "the spigot is bent and damaged, with typical marks observed in previous similar complaints, consistent with a misuse of the device".No further investigation is required at this time.If further information becomes available this investigation will be re-opened.

Event Description

According to the surgeon, one of the prongs on the spigot protector was bent when the prosthesis was unpacked.It was therefore not possible to attach it to the stem introducer, so the prosthesis was positioned by hand.There were no adverse consequences and it did not affect the outcomes the surgery.

• Brand Name: EXETER V40 STEM 37.5MM 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6963514
• MDR Text Key: 90667093
• Report Number: 0002249697-2017-03068
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 0580-1-372
• Device Lot Number: G7153667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other