MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS PROX FEM COM TROCHANTERIC; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	64951002
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The internal package was perforated and the sterility of the implant was compromised.The implant was unusable.Update 27/aug/2018: primary procedure.Surgical delay of 3 minutes to obtain a standard femoral component ((b)(4)).
Event or Problem Description
The internal package was perforated and the sterility of the implant was compromised.The implant was unusable.Update 27/aug/2018: primary procedure.Surgical delay of 3 minutes to obtain a standard femoral component (cat 6495-1-001).
Additional Manufacturer Narrative
Device evaluation analysis added.Reported event: an event regarding packaging damage involving a gmrs femoral component was reported.The event was confirmed.Conclusions: visual inspection was performed on the returned packaging.The unit carton was returned with its shrink wrap opened on one end.There is compression damage evident on the unit carton.One of the opening flaps has been torn from the unit carton.The outer blister is broken ¿ the flange on one side is completely bent up and bent out of shape and is fractured on one end.There is a dent and crack in the side of the outer blister.The inner blister pack was returned partially opened (2 sides were opened).There is a crack in the side of the inner blister.The device packaging appears to have been exposed to inappropriate handling/storage.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: GMRS PROX FEM COM TROCHANTERIC
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7893518
• Report Number: 0002249697-2018-02974
• Device Sequence Number: 19181216
• Product Code: JDI
• UDI-Device Identifier: 07613327048711
• UDI-Public: 07613327048711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023087
• 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): 11/16/2018

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: 04/30/2021
• Device Catalogue Number: 64951002
• Device Lot Number: AXT7J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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