MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HARRIS GALANTE STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Synovitis (2094); Tissue Damage (2104); Osteolysis (2377); Osteopenia/ Osteoporosis (2651)

Event Date 06/05/1997

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item #: unknown head lot #: unknown, item #: unknown liner lot #: unknown, item #: unknown cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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: 0001822565-2020-03075, 0001822565-2020-03074, 0001822565-2020-03073.

Event Description

It was reported that the patient experienced traumatic left hip injury at age (b)(6) 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.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: a1, b4, b5, b7, g4, h2.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 available at the time of this report.

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) 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 as the necessary information to adequately investigate the reported event was not provided.Medical records identified the following : the patient underwent a left total hip arthroplasty.Patient has a long history of left hip procedures and implants due to mva at the age of 14.Subsequently, the patient started experiencing instability and recurrent dislocations and underwent revision due to failed hip arthroplasty.Images revealed protrusion deformity, medial acetabulum appeared to have buttressed w/bone graft.Stem subsidence - 1.2 cm was noted.Patient had antalgic gait and groin pain that radiated down the medial aspect of the leg.There was 1.5 cm shortening.Ct scan revealed left tibia to be 2mm longer than right, left femur 8mm shorter than right.The patient suffered from recurrent dislocations.Cystic resorption and proximal femoral deficiency was noted.The acetabular component was found to be malrotated to posterior version.There was excessive wear of the cup and the acetabulum was fractured.Muscle was found to be bulging through fascia.Synovitis was present.The femur was loose.No other findings related to the reported event were noted.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: UNKNOWN HARRIS GALANTE STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10471231
• MDR Text Key: 204917672
• Report Number: 0001822565-2020-03076
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: NI
• 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: 11/03/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 08/20/2020; 11/02/2020
• Supplement Dates FDA Received: 09/15/2020; 11/03/2020
• 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
• Patient Weight: 82