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 Sticking (1597); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that, as the scrub nurse peeled back the top film layer of the exeter stem package, the sterile packaging layer underneath was bonded to the top layer.The surgeon chose not to use this implant in case sterility had been breached.Another device was used to complete the case.

Manufacturer Narrative

An event regarding a packaging issue involving an exeter stem was reported.The packaging issue of the exeter stem was confirmed following return of the device.Device evaluation and results: visual inspection of the returned device was carried out."all the packaging components and the stem were returned for evaluation.The inner tyvek and the outer tyvek are stuck together.The inner tyvek was not correctly centered and goes on the external sealing flange." medical records received and evaluation: no medical records were received for review with a clinical consultant.No adverse consequences to the patient were noted.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: nc has been raised to investigate the event.The investigation concluded that "the inner tyvek and the outer are stuck together because the inner tyvek was not correctly centered and goes on the external sealing flange.The inner tyvek was not correctly positioned due to human error, it is an isolated case.".

Event Description

The customer reported that, as the scrub nurse peeled back the top film layer of the exeter stem package, the sterile packaging layer underneath was bonded to the top layer.The surgeon chose not to use this implant in case sterility had been breached.Another device was used to complete the case.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6755404
• MDR Text Key: 81469739
• Report Number: 0002249697-2017-02342
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

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: 03/28/2022
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G7035249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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