MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HOFFMANN 1.8 THIN OLIVE WIRE(USED QTY.-4); IMPLANT

Catalog Number UNK_SEL

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Injury (2348); Fluid Discharge (2686)

Event Date 08/15/2019

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 reno orthopedic clinic, united states.The title of this report is ¿utilization of the stryker hoffmann limb reconstruction frame in patients with complex foot and ankle conditions.¿ which is associated with the stryker ¿hlrf¿ system.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device 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 10 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses implant loosening followed by revision.4 out of 6 cases.The report states: ¿all of these aes were initially related to loosening of the thin wires on the proximal ring.All (100%) of the rings were carbon and none were found in the hybrid cases with the aluminum proximal ring.Patients presented with increasing pain and drainage from their proximal pin sites.All five patients went back for surgical augmentation which included replacing the loose thin wire and augmenting with a 5.0mm ha coated half pin.¿.

• Brand Name: UNKNOWN HOFFMANN 1.8 THIN OLIVE WIRE(USED QTY.-4)
• 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: 10138588
• MDR Text Key: 194767064
• Report Number: 0008031020-2020-01574
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• 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: 05/14/2020
• 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
• Patient Age: 49 YR
• Patient Weight: 101