MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REUNION TSA HUMERAL HEAD; IMPLANT

Catalog Number UNK_SEL

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by mfr: device disposition is unknown.

Event Description

The manufacturer became aware of a study from the (b)(6) university medical center, (b)(6), usa.The title of this report is ¿simultaneous bilateral resection total shoulder arthroplasty with anatomic antibiotic cement spacer retention¿ which was published in october-2017 and is associated with the stryker reunion tsa.Within that publication, post-operative complications/ adverse events were reported.It was not possible to ascertain specific device catalog from the study; 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 study.This product inquiry addresses bilateral arthroscopic shoulder irrigation and debridement, loose glenoid component.2 out of 2 cases.Left shoulder the study reports, ¿approximately 10 days after completion of antibiotics, the patient¿s shoulder symptoms returned to a level worse than they had been previously.He presented to an outside emergency department.[.] the patient underwent bilateral arthroscopic shoulder irrigation and debridement.The glenoid components were noted to be loose bilaterally but were retained.Cultures again grew s.Aureus, and the patient was prescribed intravenous antibiotics.¿.

• Brand Name: UNKNOWN REUNION TSA HUMERAL HEAD
• 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: 8803693
• MDR Text Key: 151481589
• Report Number: 0008031020-2019-00874
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/18/2019
• 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: 66 YR