MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 3; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 0580-1-373

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received will be provided in a supplemental report.Not returned.

Event Description

Nurse (b)(6) informed sales rep that item ref 0580-1-373, lot g5861841 could not be opened in sterile way during the operation.New implant had been taken to continue operation.Operation was completed successfully, no delay.

Manufacturer Narrative

An event regarding packing issue involving an exeter stem.The report was confirmed.Method & results: device evaluation and results: a visual inspection was performed by lisi which noted all the packaging components and the stem were returned for evaluation.The outer tyvek was opened correctly and the inner tyvek is separated into two layers: the lower layer is sealed to the inner blister and the upper layer is detached.The inner tyvek was not correctly centered and goes on the external sealing flange.Medical records received and evaluation: a medical review was not performed because no medical information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: the investigation concluded that the inner tyvek and the outer were stuck together because the inner tyvek was not correctly centered and goes on the external sealing flange.So, when the customer opened the outer tyvek, the upper layer of the inner tyvek came with the outer tyvek.

Event Description

Nurse (b)(6) informed sales rep that item ref (b)(4), lot g5861841 could not be opened in sterile way during the operation.New implant had been taken to continue operation.Operation was completed successfully, no delay.

• Brand Name: EXETER V40 STEM 37.5MM NO 3
• Type of Device: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7640925
• MDR Text Key: 112417837
• Report Number: 0002249697-2018-01969
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540153272
• UDI-Public: 04546540153272
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

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: 12/31/2020
• Device Catalogue Number: 0580-1-373
• Device Lot Number: G5861841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other