MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6052-0730S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate 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.Not returned.
Event or Problem Description
As reported: "subsided femoral stem.Re-implanted with new stem.".
Additional Manufacturer Narrative
An event regarding loosening involving a securfit stem.The event was confirmed as a result of a medical review.Method & results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records by a clinical consultant noted there are many records and they all document a loose and subsided stem with pain but none provides any clue to the cause of the problem.The stem may be undersized, have malposition or otherwise but such requires x-rays for diagnosis and these are not available.There is significant obesity of the patient but this alone is rarely a root cause for failure.If implantation conditions are optimal, obesity should not lead to failure.So, the cause of the problem remains obscure.The stem was revised to a restoration modular construct while retaining the cup without issues.This case can unfortunately not be solved with the current information but clearly requires x-rays for better understanding of the problem.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.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.
Event or Problem Description
As reported: "subsided femoral stem.Re-implanted with new stem.".

• Brand Name: SECUR-FIT MAX 127 HIP STEM #7
• 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: 7326502
• Report Number: 0002249697-2018-00683
• Device Sequence Number: 10789030
• Product Code: LZO
• UDI-Device Identifier: 07613327021103
• UDI-Public: 07613327021103
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 04/10/2018

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: 06/30/2022
• Device Catalogue Number: 6052-0730S
• Device Lot Number: LA1XNH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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: 62 YR
• Patient Weight: 107