MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE KK NEUTRAL LINER; PROTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign: country: japan.Cat# 650-1162 lot# 2016090308 delta cer fem hd 32/0mm t1 cat# 51-145130 lot# 51-145130 tprlc xr mp t1 pps 13x111mm cat# 00875705602 lot# 63103104 56mm o.D.Size kk porous uncemented multi-holes shell customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001822565-2024-00420.

Event Description

It was reported that approximately 7 years post implantation of a right total hip arthroplasty, the patient was revised due to pain and osteolysis.The cup and head were replaced.There were no contributing conditions related to the event.No additional information.

• Brand Name: 32MM I.D. SIZE KK NEUTRAL LINER
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18685832
• MDR Text Key: 335132294
• Report Number: 0001822565-2024-00421
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00885101232
• Device Lot Number: 63128397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2015
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose