MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN RHEAD; IMPLANT

Catalog Number UNK_SEL

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/01/2002

Event Type  Death  

Manufacturer Narrative

The reported event that stryker rhead was alleged that the patient died could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information is available.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.Based on the investigation, no relation could be established between the product and the resulting adverse consequence.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.

Event Description

The manufacturer became aware of adverse events from the norwegian arthroplasty register (nar).The title of this report is ¿rhead reported in the norwegian arthroplasty register (nar)¿ which is associated with the rhead system, within that report, post-operative complications/ adverse events were reported, which occurred between 2002 and 2017.A review of the complaint handling database revealed that the events have not been reported previously to stryker, therefore 3 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses death after the primary operation, the exact the date of the death will not be disclosed.2 out of 2 cases.

• Brand Name: UNKNOWN RHEAD
• 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: 7861993
• MDR Text Key: 119782259
• Report Number: 0008031020-2018-00602
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2018
• 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): Death