MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEADSTERILE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Inflammation (1932); Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Component code: (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 00428.Reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.Device location unknown.

Event Description

It was reported patient underwent a revision surgery approximately 2 years post implantation due to unknown reason.During the revision the head and stem were exchanged.No additional information available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4;g3;h2;h3;h6.H6: component code: mechanical (g04) - head.No product was returned, or pictures provided; visual and dimensional evaluation could not be performed.Medical records were provided and reviewed by a health care professional.A review of the available records identified the following: the patient had an initial right tha.Subsequently, a revision was performed due to pain, tendinitis, and elevated metal ions.During the revision, wear was found around the trunnion, and the tendons around the trochanter needed repair.The head, neck, and liner were exchanged with no complications noted.The reported issue was confirmed based on the provided medical records.Lot identification is necessary for review of device history records; however, lot identification was not provided.The reported products were reviewed for compatibility with no issues noted.The additional information does not change the outcome of the previous investigation.A definitive root cause cannot be determined.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

No further event information is available at the time of this report.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;d9;g3;h2;h3;h6.The following section was corrected: d10.D10: cat# 00875105201 lot# 63938952 tm it acet shell cluster 52 ii product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that approximately 4 years post implantation of a right total hip arthroplasty, the patient was revised due to pain, tendinitis, and elevated cobalt and chromium levels.During the revision, trunnion wear was noted.The greater trochanter also had a partial under-surface detachment of the abductor tendon with moderate degeneration which included the gluteus medius and minimus.The well-fixed shell and stem were left intact, and all other components were revised without complication.No additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.D10: cat# 00875105201 lot# 62939248 tm it acet shell cluster 52 ii cat# 00625006530 lot# unknown bone scr 6.5x30 self-tap cat# 00625006520 lot# unknown bone screw self-tapping 6.5 mm dia.20 mm length cat# 00771300700 lot# unknown modular femoral stem press-fit.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.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.D10: cat# 00784800200 lot# 63239625 modular neck k 12/14 neck taper.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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 2648920.

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 2648920.

• Brand Name: FEMORAL HEADSTERILE 12/14 TAPER
• 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: 16425975
• MDR Text Key: 310041616
• Report Number: 0001822565-2023-00430
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2024

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 Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 64082926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 05/22/2023; 06/19/2023; 08/17/2023; 09/11/2023; 01/03/2024
• Supplement Dates FDA Received: 06/16/2023; 06/20/2023; 09/14/2023; 09/21/2023; 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female