MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 35.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-351

Device Problems Connection Problem (2900); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during a tha, a surgeon could not connect the exeter stem with the stem inserter due to a deformation of the spigot protector.

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 of the returned device was carried out by the supplier they noted "the yellow spigot shows a bent lug.We can see high material deformation on the bent lug, exactly located on the area where the stem inserter has to connect with the spigot.Dimensional and functional inspection was not performed as the returned device was too damaged to allow either dimensional or functional inspection.-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 "that bent spigots are not due to a manufacturing defect.The returned spigot shows bent lugs and visual marks of material bulge that are 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

It was reported that, during a tha, a surgeon could not connect the exeter stem with the stem inserter due to a deformation of the spigot protector.

• Brand Name: EXETER V40 STEM 35.5MM
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6255924
• MDR Text Key: 65352102
• Report Number: 0002249697-2017-00244
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

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: 09/30/2021
• Device Catalogue Number: 0580-1-351
• Device Lot Number: G6104842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2016
• 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