MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SECUR-FIT MAX 127 HIP STEM #8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6052-0830S
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Fall (1848); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Sales rep reported a right hip revision due to subsided stem of patient.Surgeon revised another surgeon revision at the same hospital.As per sales representative, patient fell and on (b)(6) 2017, a trochanter plate was implanted.The plate was not a stryker device.No other devices were removed.
Additional Manufacturer Narrative
An event regarding subsidence involving a securfit stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned device noted that bone ongrowth was visible on the stem.The device was otherwise visually unremarkable.Furthermore, returned device was consulted with the material analysis engineer who indicated that "material analysis is not performed as the reported event indicates the patient experienced a traumatic event.The material integrity of the device cannot be determined due to patient trauma." medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided.Visual inspection of the returned device noted that bone ongrowth was visible on the stem.Furthermore, returned device was consulted with the material analysis engineer who indicated that "material analysis is not performed as the reported event indicates the patient experienced a traumatic event.The material integrity of the device cannot be determined due to patient trauma." no further investigation is required at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Sales rep reported a right hip revision due to subsided stem of patient.Surgeon revised another surgeon revision at the same hospital.As per sales representative, patient fell and on (b)(6) 2017, a trochanter plate was implanted.The plate was not a stryker device.No other devices were removed.

• Brand Name: SECUR-FIT MAX 127 HIP STEM #8
• 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: 6597557
• Report Number: 0002249697-2017-01715
• Device Sequence Number: 78783
• Product Code: LZO
• UDI-Device Identifier: 07613327021110
• UDI-Public: (01)07613327021110(11)160505(17)210505(10)1D3XJR
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: 05/31/2021
• Device Model Number: 6052-0830S
• Device Catalogue Number: 6052-0830S
• Device Lot Number: 1D3XJR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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: 66 YR
• Patient Weight: 61