MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 8 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1601-08127
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's left hip was revised.Revision implants were a stem, head, and 4 beaded cables.
Event or Problem Description
It was reported through the submission of a revision implant sheet that patient's left hip was revised.Revision implants were a stem, head, and 4 beaded cables.
Additional Manufacturer Narrative
An event regarding revision involving a security stem was reported.The event was confirmed as following a review of the provided revision implant sheet.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: 127 SIZE 8 SECUR-FIT ADVANCED STEM
• 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: 7249891
• Report Number: 0002249697-2018-00361
• Device Sequence Number: 16340106
• Product Code: LPH
• UDI-Device Identifier: 07613327021318
• UDI-Public: 07613327021318
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 1601-08127
• Device Lot Number: PK2VM5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/13/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 53