MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M/L TAPER FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Scar Tissue (2060); Patient Problem/Medical Problem (2688); No Information (3190)

Event Date 01/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event is unable to be confirmed due to limited information provided by the customer.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is unable to 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00222.0001822565 - 2020 - 01320.

Event Description

It was reported that patient underwent a right hip revision approximately 7 years post implantation due to unknown reasons.The head, stem and neck were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: 00801803202 ¿ cocr head ¿ 62480002; 00784801300 ¿ m/l taper neck ¿ 62458886; 00620005222 ¿ trilogy cup ¿ 62498666; 00631005032 ¿ liner - 62483455.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01651.Updated investigation is in process and a follow-up mdr will be submitted upon completion.

Event Description

It was reported that patient underwent a right hip revision approximately 7 years post implantation due to pain and elevated metal ion levels.During the procedure, altr was noted due to corrosion of the neck-stem taper.The shell was also noted as being malposition, but was left intact.All other components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

His follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting that during the revision procedure, corrosion was observed between the femoral neck and distal stem's taper.The head was not removed from the neck; therefore, the neck-head junction was not inspected.An extended osteotomy was performed to remove all femoral components and the neck and head were removed attached to each other.Altr and scar tissue were present in the joint.The acetabular component was in a very horizontal and overly anteverted position.This was compensated for by a polyethylene insert inside the acetabular component with a 20mm lip placed anterior and slightly inferior.This reduced the anteversion of the cup somewhat but was still very horizontal.The shell had a solid ingrowth and was securely fixed.The head, liner, stem, neck, and a bone screw were removed and new zimmer biomet products were implanted.No other complication/ significant findings were noted.Dhr was reviewed and no discrepancies were found.The additional information does not change the outcome of the previous investigation.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 additional event information to report at this time.

• Brand Name: M/L TAPER FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9943207
• MDR Text Key: 187201448
• Report Number: 0001822565-2020-01319
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2020

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: 00771300700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 04/15/2020; 07/31/2020
• Supplement Dates FDA Received: 05/06/2020; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN NECK; UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN LINER; UNKNOWN NECK
• Patient Outcome(s): Hospitalization; Required Intervention