MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN RHEAD PROSTHESIS; IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Injury (2348)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.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 study from (b)(6).The title of this report is ¿terrible triad of the elbow: is it still a troublesome injury¿ which is associated with the stryker rhead system.Within that publication, post-operative complications/adverse events were reported which occurred between 2008 to 2013.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 6 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses elbow stiffness and transient ulnar neuropathy (case 2).The study states: ¿following the first operation, five cases of elbow stiffness (2 mixed and 3 extrinsic contractures) were observed (cases 2, 3, 4, 9 and 16): [¿] moreover, four out of five of these patients were obese (body mass index >30) and all five displayed limited compliance (defined as a severe difficulty or inability to perform rehabilitation exercises and to use correctly the elbow brace and follow the surgeon¿s indications) during rehabilitation.[¿] the e-f plane alone was involved in one of these five contractures, which was consequently classified as moderate.[¿] four (cases 2, 3, 9 and 16) of these five patients underwent open debridement.¿.

Event Description

The manufacturer became aware of a study from (b)(6) rome, italy.The title of this report is ¿terrible triad of the elbow: is it still a troublesome injury¿ which is associated with the stryker rhead system.Within that publication, post-operative complications/adverse events were reported which occurred between 2008 to 2013.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 6 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses elbow stiffness and transient ulnar neuropathy (case 2).The study states: ¿following the first operation, five cases of elbow stiffness (2 mixed and 3 extrinsic contractures) were observed (cases 2, 3, 4, 9 and 16): [¿] moreover, four out of five of these patients were obese (body mass index >30) and all five displayed limited compliance (defined as a severe difficulty or inability to perform rehabilitation exercises and to use correctly the elbow brace and follow the surgeon¿s indications) during rehabilitation.[¿] the e-f plane alone was involved in one of these five contractures, which was consequently classified as moderate.[¿] four (cases 2, 3, 9 and 16) of these five patients underwent open debridement.¿.

Manufacturer Narrative

New information in section h6 (device code and patient code).

• Brand Name: UNKNOWN RHEAD PROSTHESIS
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9439338
• MDR Text Key: 185699190
• Report Number: 0008031020-2019-02044
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• 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: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR