MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTEGRAL REVISION 15X225MM LF; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/04/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown, unknown head lot #: unknown.Item #: unknown, unknown liner lot #: unknown.Item #: unknown, unknown cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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: 0001825034 - 2020 - 03104.0001825034 - 2020 - 03105.0001825034 - 2020 - 03106.

Event Description

It was reported that patient underwent left total hip arthroplasty and was revised seventeen years later due to pelvic bone fracture.The patient claims to still be in pain and has difficulty standing and walking.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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

It was reported that the patient experienced traumatic left hip injury at age 14 and had a cup arthroplasty performed.Nine years later, the patient tripped and fell.The fall trauma resulted in a full left hip replacement.The patient was revised seven years post initial full hip replacement due to pain, recurrent dislocations and instability.Patient revised again twenty four years post full tha due to pain and pelvic bone fracture.She was told her hip stem was too long and she walked on it wrong for years causing her pelvic to snap.During the revision her surgeon was unable to remove the stem due to it being too deep.He opted to revise her acetabular side to compensate.Patient reports that she is still in pain and has difficulty standing and walking.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: a5, b3, b4, b5, b7, d3, d11, g4, h2.D11: 00631005836 liner 10 degree elevated rim 3.5 mm 62496983, 00620205820 shell porous with multi holes 58 mm 62585112, 650-1057 cer bioloxd option hd 36mm 057690, 650-1065 cer option type 1 tpr sleve 997140, 00625006540 bone scr 6.5x40 self-tap 62405649, 00625006515 bone scr 6.5x15 self-tap 62553201, 00625006520 bone scr 6.5x20 self-tap 62572389, 00625006520 bone scr 6.5x20 self-tap 62405627, 00625006515 bone scr 6.5x15 self-tap 77002842, 00625006520 bone scr 6.5x20 self-tap 62528851.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03112, 0001822565 - 2020 - 03113.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

It was reported that the patient experienced traumtic left hip injury at age 14 and had a cup arthroplasty performed.Nine years later, the patient tripped and fell.The fall tramua resulted in a full left hip replacement.The patient was revised seven years post initial full hip replacement due to pain, recurrent dislocations and instability.Patient revised again twenty four years post full tha due to pain.Patient continues to suffer from paint and has difficulty walking.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies related to the event were found.Root cause was unable to be determined.Medical records identified the following : the patient underwent a left total hip arthroplasty and was revised four years later when the patient began experiencing instability and recurrent dislocations.Patient underwent another revision procedure during when, zimmer biomet components were implanted.The patient underwent another revision procedure due to failed hip arthroplasty - acetabular loosening, migration, osteolysis, bone resorption, and heterotopic ossification.The head, cup, and liner were removed and new zimmer biomet products were implanted.The patient continued to suffer from pain and difficulty ambulating following the revision.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: INTEGRAL REVISION 15X225MM LF
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10386778
• MDR Text Key: 202354803
• Report Number: 0001825034-2020-03103
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2006
• Device Model Number: N/A
• Device Catalogue Number: 166025
• Device Lot Number: 317640
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 08/20/2020; 12/01/2020
• Supplement Dates FDA Received: 08/21/2020; 09/01/2020; 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 82