MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN IMPLANT; PROSTHETIC, HIP

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374)

Event Date 05/03/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 650-1055 cer bioloxd option hd 28mm 3120162; 110031017 vivacit-e dm bearing 28x54mm 65369911; 650-1065 cer option type 1 tpr sleve -3 3137043; 11-300817 arcos 17x150mm spl tpr dist 122710; 00-6250-065-35 trilogy bone scr 6.5x35 65847193; 110010251 g7 osseoti 4 hole shell 6530909.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted h3 other text : device location is unknown.

Event Description

It was reported patient underwent a revision procedure 5 days post-implantation due to a dislocation.There is no additional information available at the time of this report.

Event Description

It was reported patient underwent a revision procedure 5 days post-implantation due to an infection of an unknown cement spacer.There is no additional information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Unable to confirm complaint, part/lot unknown and no medical records provided.Medical records were not provided.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection 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.

Event Description

It was reported that the patient underwent a revision procedure 5 days post-implantation due to an infection of an unknown implant.A cement spacer was placed to treat the infection after implant removal.There is no additional information available at the time of this report.

• Brand Name: UNKNOWN IMPLANT
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16930242
• MDR Text Key: 315199020
• Report Number: 0001825034-2023-01052
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 110024467
• Device Lot Number: 069510R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2023
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male