MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM HEAD 28 MM DIAMETER MEDIUM 7 MM NK LGTH; PROSTHESIS, HIP

Catalog Number 00902602900

Device Problem Material Erosion (1214)

Event Type  Injury  

Event Description

It was reported a patient has been indicated for a right hip revision approximately 19 years post implantation due to loosening and elevated metal ion levels.The shell that is to be revised is a competitor product.To date, no revision has taken place.Attempts have been made and no further information is available.

Manufacturer Narrative

(b)(4).Multiple mdr reports.Were filed for this event, please see associated reports: 0001822565-2023-02269 d10: cat #: 6302-1-058 / howmedica acetabular vitalcok cluster shell 58mm / lot #: crtzd9420292; cat #: 00663001600 / multilock femoral stem 16 mm / lot #: 73950600.G2: canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; g3; h2; h6 corrected: d1; d4 an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

No additional event information to report at this time.

Event Description

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).

Manufacturer Narrative

(b)(4).Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number: (b)(4).

• Brand Name: FEM HEAD 28 MM DIAMETER MEDIUM 7 MM NK LGTH
• Type of Device: PROSTHESIS, 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: 17630509
• MDR Text Key: 322027787
• Report Number: 0001822565-2023-02268
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K960278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00902602900
• Device Lot Number: 60060928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 10/19/2023
• Supplement Dates FDA Received: 09/26/2023; 10/27/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male