MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.

Catalog Number	2030-6530-1
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	06/29/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding loosening of the trident shell and crack/fracture of the bone screw was reported.The event of loosening and crack/fracture was confirmed by medical review.Method & results: product evaluation and results: visual, dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: ¿no patient demographics are given, there are no x-rays available for review, and there is no examination of the explanted components noted.There is no documented follow-up for the period between (b)(6) 2008 and (b)(6) 2011.¿ ¿based upon the information reviewed, it is not possible to determine the cause of the loose left acetabular component requiring revision surgery three years and eight months status-post implantation in this case.¿ product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the reported event for ¿the patient is experiencing, 'loosening' from the system" was confirmed but the root cause could not be determined.It was noted in the clinician¿s review, as mentioned in the operative report, ¿the cup was removed without major bone loss and during removal a broken screw was noted, which was retrieved except for a small retained tip of the screw that remained in the bone.¿ as noted by the clinician the root cause could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.If further information becomes available the investigation will be reopened and re-evaluated.
Event or Problem Description
It was reported through the attorney for the patient, as a result of a legal claim that allegedly, "the patient received a trident acetabular hip system." it was further alleged that the patient is experiencing, 'loosening' from the system." updated per medical review: ¿on (b)(6) 2011 a revision of the left total hip arthroplasty acetabular component was performed for a diagnosis of failed acetabular component left hip.The cup was removed without major bone loss and during removal a broken screw was noted, which was retrieved except for a small retained tip of the screw that remained in the bone.The report notes,".Bone grafting the deficit of the acetabulum", and a 54mm cup with two screws was utilized, along with a 36/0° x3 insert, all by uncomplicated surgery.¿.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Common Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7861893
• Report Number: 0002249697-2018-02816
• Device Sequence Number: 13948292
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2018

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: 01/31/2012
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: J43MAD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/10/2018
• 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: 45