MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 132 SIZE 10 SECUR-FIT ADVANCED STEM; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	1601-10132
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that upon opening the outer sterile blister of the device, the inner sterile blister was observed to be unsealed.Surgeon elected to not use the device due to sterility concerns.A second device was immediately available in the operating room with no surgical delay.
Additional Manufacturer Narrative
An event regarding packaging issue involving a securfit stem was reported.The event was confirmed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event for packaging issue was confirmed based on visual inspection of the returned device.The returned packaging of the securfit stem had the inner blister bent and part of the tyvek lid was not sealed.According to the nc¿s noted process, each stage of the packaging and sealing process are visual inspections.At any point in the process if any packaged device has issues they are discontinued and removed from the process.As there was no report of an issue with the outer seal, the issue with the inner seal had no impact on the quality, functionality, or sterility of the implant.The product was not used in surgery and a backup unit was immediately available for implant, causing no delay to surgery.
Event or Problem Description
It was reported that upon opening the outer sterile blister of the device, the inner sterile blister was observed to be unsealed.Surgeon elected to not use the device due to sterility concerns.A second device was immediately available in the operating room.With no surgical delay.

• Brand Name: 132 SIZE 10 SECUR-FIT ADVANCED STEM
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7971176
• Report Number: 0002249697-2018-03398
• Device Sequence Number: 1488360
• Product Code: LPH
• UDI-Device Identifier: 07613327021363
• UDI-Public: 07613327021363
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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: 03/30/2019
• Device Catalogue Number: 1601-10132
• Device Lot Number: MNA69P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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
• Patient Age: 64 YR