MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 132 HIP STEM #10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6051-1035S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	12/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding subsidence involving a securfit stem was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: not performed as no medical information was provided.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event itself could not be confirmed nor could the exact cause of the event be determined because insufficient information was provided.Further information such as product return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient underwent a primary total hip replacement (b)(6) 2017.She did fine until recent follow up showed subsidence of the stem.She had a leg length discrepancy.She was scheduled for revision.The stem was removed and replaced with a restoration modular cone conical stem.Operation was completed successfully.

• Brand Name: SECUR-FIT MAX 132 HIP STEM #10
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8218992
• Report Number: 0002249697-2019-00047
• Device Sequence Number: 1592870
• Product Code: LZO
• UDI-Device Identifier: 07613327021042
• UDI-Public: 07613327021042
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K051738
• 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
• Report Date (Section B): 01/04/2019

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: 10/31/2021
• Device Catalogue Number: 6051-1035S
• Device Lot Number: D1754A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2018
• Initial Report FDA Received Date: 01/04/2019
• 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: 83 YR
• Patient Weight: 72