MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK RINGLOC BIPOLAR CUP; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Pneumonia (2011)

Event Type  Death  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Takuya nakamura, toru yamakawa , junji hori , hisataka goto , akihiko nakagawa , tetsuro takatsu , naoki osamura , atsushi saito , keisuke hagio and kanto mouri.(2021) conjoined tendon preserving posterior approach in hemiarthroplasty for femoral neck fractures: a prospective multicenter clinical study of 322 patients.Journal of orthopaedic surgery.29 (3) 1-8.(b)(6).Concomitant medical products: unknown ringloc bipolar cup, unknown taperloc stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00768, 0001825034-2022-00769.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported in a journal article that 8 patients experienced pneumonia and expired in an unknown time frame postoperatively.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

Event Description

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

• Brand Name: UNK RINGLOC BIPOLAR CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13953270
• MDR Text Key: 288266445
• Report Number: 0001825034-2022-00769
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/I
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/20/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Death; Other