MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 14.0; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Impaired Healing (2378)

Event Date 02/20/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).650-1057, cer bioloxd option hd 36mm, unknown; unknown, unknown mh ringloc shell, unknown; unknown, unknown e1 maxrom liner, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06151, 0001825034-2018-06150, 0001825034-2018-06148.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [remains implanted].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient's left hip underwent i&d due to nonhealing surgical wound approximately one month post implantation.No further information is available at this time.

Manufacturer Narrative

Upon reassessment of the complaint it was determined that the complaint was already reported on 0001825034-2015-00947.The initial report submitted should be voided.

• Brand Name: TPRLC 133 MP TYPE1 PPS HO 14.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7753676
• MDR Text Key: 116207618
• Report Number: 0001825034-2018-06152
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

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: 51-107140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 09/26/2018
• 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 Age: 60 YR
• Patient Weight: 116