MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 132 SIZE 5 SECUR-FIT ADVANCED STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1601-05132
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product 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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Sale rep reported, during a hemi arthroplasty the prosthesis receded further than intended.Surgeon stated the prosthesis appeared to be smaller than the size 5.Surgeon proceeded with a size 6 prosthesis and completed surgery successfully.It was noted by the rep that there was a fracture on the bone and suspects that the stem moved due to the fracture.There was approximately a 5 minute surgical delay.
Additional Manufacturer Narrative
Reported event: an event regarding a size/fit issue and intraoperative fracture involving a securfit stem was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned device noted the following: nothing remarkable to report.Dimensional inspection on the returned device was not performed as the device was processed through cp titanium coating process by aps-materials, inc.And there are no dimensional specifications of the post-coating devices.100% dimensional inspection and coating thickness inspection was completed on the devices of reported lot.Refer to product history review section for details.Functional inspection was not performed because the event does not relate to device function.Material analysis is not performed as this is not related to material integrity.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There were 100% dimensional inspection conducted prior to the cp titanium coating process and all 5 devices met the dimensional inspection.Coating thickness inspection of the 5 devices was completed and all met the specification.Complaint history review: there have been no other similar events for the reported lot.Conclusions: based on the device history review, there were 100% dimensional inspection conducted prior to the cp titanium coating process and all 5 devices met the dimensional inspection.Coating thickness inspection of the 5 devices was completed and all met the specification.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays 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
Sale rep reported, during a hemi arthroplasty the prosthesis receded further than intended.Surgeon stated the prosthesis appeared to be smaller than the size 5.Surgeon proceeded with a size 6 prosthesis and completed surgery successfully.It was noted by the rep that there was a fracture on the bone and suspects that the stem moved due to the fracture.There was approximately a 5 minute surgical delay.

• Brand Name: 132 SIZE 5 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: 8523464
• Report Number: 0002249697-2019-01646
• Device Sequence Number: 19324220
• Product Code: LPH
• UDI-Device Identifier: 07613327021264
• UDI-Public: 07613327021264
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 12/31/2021
• Device Catalogue Number: 1601-05132
• Device Lot Number: X91PX4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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