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
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received will be provided in a supplemental report.Not returned.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7640925
• Report Number: 0002249697-2018-01969
• Device Sequence Number: 14047415
• Product Code: JDI
• UDI-Device Identifier: 04546540153272
• UDI-Public: 04546540153272
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other