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

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 03/20/2019

Event Type  Injury  

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 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.

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 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
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8523464
• MDR Text Key: 142237113
• Report Number: 0002249697-2019-01646
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327021264
• UDI-Public: 07613327021264
• Combination Product (y/n): N
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 91 YR