MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 127 SIZE 7 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1601-07127
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Sales rep reported patient is mentally challenged, not sure if she suffered a falland fracture.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a securfit stem was reported.The event was confirmed.Method & results: -device evaluation and results: device was not returned however, inspection of provided explanted image shows some blood stains on stem.Nothing else can be determined from the explanted images.-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 of revision was confirmed as explanted image of stem was provided which shows some blood stains on it.The root cause of the event could not be determined because device was not returned for evaluation and insufficient information was provided.No further investigation is required at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Sales rep reported patient is mentally challenged, not sure if she suffered a fall & fracture.

• Brand Name: 127 SIZE 7 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: 6452930
• Report Number: 0002249697-2017-01101
• Device Sequence Number: 13797581
• Product Code: LPH
• UDI-Device Identifier: 07613327021295
• UDI-Public: (01)07613327021295(11)161117(17)211130(10)R00780
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2017

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: 11/30/2021
• Device Catalogue Number: 1601-07127
• Device Lot Number: R00780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 06/09/2017
• 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: 64 YR
• Patient Weight: 72