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
Medical Device Problem Codes	Sticking (1597); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6755404
• Report Number: 0002249697-2017-02342
• Device Sequence Number: 16173372
• Product Code: LPH
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 11/17/2017
• 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