MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PRO SUPRAPECTINEAL PLATE QLS; IMPLANT

Catalog Number UNK_SEL

Device Problem Separation Problem (4043)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a pmcf from (b)(6).The title of this report is ¿a retrospective data collection of the treatment of pelvis and acetabulum fractures with the pro system¿ which is associated with the stryker ¿pro¿ system.Within that publication, post-operative complications/adverse events were reported, which occurred from 2014 to 2019.It was not possible to ascertain specific device/patient details from the report, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 8 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses screw migration requiring percutaneous removal.The report states: ¿this patient sustained a left sided periprosthetic acetabular fracture following a fall from a ladder.They were admitted to a regional district general hospital and treated for an infective exacerbation of copd.They were transferred to southampton general hospital for pelvic fixation eight days post fall.Fixation occurred two days later.Subsequent to discharge, on review in clinic it was noted that a single screw had migrated from its post op position and could be felt subcutaneously.This was noted on review in clinic 178 days post-op.The screw was removed successfully and the patient¿s recovery was not affected.The patient was subsequently lost to follow-up.¿.

• Brand Name: UNKNOWN PRO SUPRAPECTINEAL PLATE QLS
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10076825
• MDR Text Key: 191718139
• Report Number: 0008031020-2020-01515
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention