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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL; PROTHESIS, HIPS

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ZIMMER BIOMET, INC. LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL; PROTHESIS, HIPS Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Pulmonary Embolism (1498); Hematoma (1884); Pain (1994); Joint Dislocation (2374); Respiratory Failure (2484)
Event Date 08/26/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).D10: 00620005622 shell porous with cluster holes 56 mm o.D.62954811.00625006550 bone screw self-tapping 6.5 mm dia.50 mm length 63003489.650-0662 delta ceramic fem hd 36/+3mm 3053017.Customer has indicated that 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
It was reported that a patient underwent an initial left total hip arthroplasty.One year post implantation, the head and stem were revised due to loosening of the femoral component with failure to osseointegrate.The patient was revised for a second time, five years post implantation due to fracture of the revision stem with complicated extraction via extended trochanteric osteotomy.After the second revision, the patient experienced recurrent dislocations requiring closed reduction under anesthesia.A third revision was planned but delayed due to difficulty extubating the patient and the concurrent onset bilateral pulmonary embolisms.After the patient¿s pulmonary function and anticoagulation measures were stabilized, the revision occurred during which, multiple hematomas were evacuated from the joint, and posterior instability was confirmed on exam.Upon replacing the acetabular shell, anteversion was increased by 15 degrees.A new constrained head and liner were placed within the shell, and the revision stem was retained.Postoperatively, the patient demonstrated slow but steady progress with intensive physical therapy.
 
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Brand Name
LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL
Type of Device
PROTHESIS, HIPS
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 Key18825307
MDR Text Key336744100
Report Number0001822565-2024-00726
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/01/2024
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 Lay User/Patient
Device Model NumberN/A
Device Catalogue Number00630505636
Device Lot Number63687030
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/06/2024
Initial Date FDA Received03/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age55 YR
Patient SexMale
Patient Weight145 KG
Patient RaceWhite
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