MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN CARPAL BALL IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Burning Sensation (2146); Numbness (2415)

Event Date 09/09/2020

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 post market clinical follow-up report received from the (b)(6) center, in usa.The title of this report is ¿remotion total wrist arthroplasty: retrospective evaluation of outcomes during the first postoperative year¿ which is associated with the stryker ¿remotion total wrist system¿.This study includes research done on 21 patients requiring surgery between the period 2014 and 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses cutaneous nerve paresthesia that resolved spontaneously.The report states: ¿one patient presented 29 days postoperative with complaints of numbness and a burning sensation to the dorsum of the middle and ring fingers.The provider suspected this to be due to cutaneous nerve irritation during surgical retraction.Symptoms continued at 3 months postoperatively and radiographs confirmed no implant concerns.The patient was referred for formal electrodiagnostics that revealed incidental ulnar nerve changes and no further peripheral nerve findings.At the time of final follow-up, 7 months postoperative, the patient stated the numbness and burning had improved and the issue was resolved¿.

• Brand Name: UNKNOWN CARPAL BALL IMPLANT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10659038
• MDR Text Key: 211030166
• Report Number: 0008031020-2020-02307
• Device Sequence Number: 1
• Product Code: JWJ
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2020
• 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): Other