MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE SRS SEAS HUMERAL HEAD; PROSTHESIS, SHOULDER

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Necrosis (1971); Post Operative Wound Infection (2446)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref: 211226, lot: 938550, intercalary segment 90mm; ref: 211258, lot: 314970, modular stem 9x75mm; ref: 211228, lot: 216410, regenerex augment small; ref: 211223, lot: 484220, proximal body 71mm; ref: b000-0185 lot: 6m9704, stryker universal cement restrictor; ref: 6197-1-001 lot: tmz046, antibiotic simplex p qty: 2.Report source: foreign country: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 02522, 0001825034 - 2019 - 02523, 0001825034 - 2019 - 02525, 0001825034 - 2019 - 02526.Implanted.

Event Description

It has been reported that patient experienced wound dehiscence, necrosis, and superficial infection one month post initial surgery.The wound was closed with suture.No additional patient consequences were reported.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Reported event was considered as the medical records confirmed the patient's ailments.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE SRS SEAS HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8688785
• MDR Text Key: 147650567
• Report Number: 0001825034-2019-02524
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K111746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 211278
• Device Lot Number: 672550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80