MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Infiltration into Tissue (1931); Local Reaction (2035); Joint Dislocation (2374); Reaction (2414); Blood Loss (2597); No Information (3190)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products- part: 00771101100 femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 standard offset lot: unknown, part: 98000120011 por st/tm cup/lg xlpe ln/lg lot: unknown, part: 00620205422 shell porous with cluster holes lot: unknown, part: 00630505036 liner standard 3.5 mm offset lot: unknown.Multiple mdr reports were filed for this event, please see associated reports: stem: 0001822565-2019-02139.

Event Description

It was reported that a patient underwent left total hip arthroplasty and subsequently underwent a revision procedure six years later for allegations of unknown injuries.The head and stem were removed and replaced.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: head: 0002648920-2019-00355, stem: 0001822565-2019-02139, liner: 0001822565-2019-02867, cup: 0001822565-2019-02868.

Event Description

It was reported that a patient underwent initial left total hip arthroplasty.Subsequently, the patient was revised approximately six years post-implantation due to dislocation of the left total hip.During the procedure, the surgeon noted metallosis and trunnionosis which resulted in adverse local tissue reaction (altr) with formation of a large pseudotumor.All zimmer biomet product was removed and competitor product was re-implanted.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records.X-ray note states: superior dislocation of the femoral component of the prosthesis from the acetabular component.Satisfactory reduction of the femoral head dislocation.Another x-ray report demonstrated that there is adverse local tissue reaction.Revision op note demonstrated that the patient was revised due to dislocation of the left total hip with development of metallosis and trunnionosis resulting in altr with formation of a large pseudotumor and elevated metal ion levels.Estimated blood loss of 1000ml during the procedure was also noted.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D11: part: 00771101100, femoral stem 12/14 neck taper size 11 standard offset, lot: 62141471.Part: 00630505036, liner standard 3.5 mm offset 36 mm, lot: 62175111.Part: 00620205422, shell porous with cluster holes 54 mm, lot: 62076380.

Event Description

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

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Dhr was reviewed and no discrepancies were found.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.

• Brand Name: FEMORAL HEAD 12/14 TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8634593
• MDR Text Key: 145896964
• Report Number: 0002648920-2019-00355
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/04/2020

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 Expiration Date: 09/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 62177099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 06/10/2019; 08/16/2019; 09/24/2019; 02/04/2020
• Supplement Dates FDA Received: 07/09/2019; 08/29/2019; 10/18/2019; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention