MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SCREW, FIXATION, BONE

Catalog Number	2030-6530-1
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	12/11/2017
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 has been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
It was reported that patient's left hip was revised after patient complaint of pain.Intra-operatively, the surgeon reported that the 30mm screw was broken.Patient was revised to an mdm construct.A medical review by clinical consultant states "cup malposition in medialized position with additional adverse short leg length effects has contributed to an overload condition in the arthroplasty contributing to cup loosening requiring revision.".
Additional Manufacturer Narrative
An event regarding crack/fracture involving a bone screw was reported.The event was confirmed.Method & results: -device evaluation and results: not performed as device was not returned.-medical records received and evaluation: a review of the provided x-rays by a clinical consultant noted the following; [.] procedure-related factors: - cup malposition in medialized position.- major leg length difference, left hip short.Patient-related factors - no info.Device-related factors: - none.Diagnosis: - cup malposition in medialized position with additional adverse short leg length effects has contributed to an overload condition in the arthroplasty contributing to cup loosening requiring revision.[.] -device history review: review indicated all devices were manufactured and accepted into final stock with no relevant 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 patient details, operative reports and return of device are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
It was reported that patient's left hip was revised after patient complaint of pain.Intra-operatively, the surgeon reported that the 30mm screw was broken.Patient was revised to an mdm construct.A medical review by clinical consultant states "cup malposition in medialized position with additional adverse short leg length effects has contributed to an overload condition in the arthroplasty contributing to cup loosening requiring revision.".

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7167968
• Report Number: 0002249697-2018-00058
• Device Sequence Number: 13816779
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 03/01/2018

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: 03/15/2021
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: 3R5DM6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/01/2018
• 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: 78 YR