MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.; PROSTHESIS, HIP

Model Number N/A

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Wound Dehiscence (1154); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tissue Damage (2104); Osteolysis (2377); Blood Loss (2597); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00625006540 bone scr 6.5x40 self-tap 61013586, item #: unknown unknown stem lot #: unknown, item #: unknown unknown head lot #: unknown, item #: unknown unknown liner lot #: unknown, item #: unknown unknown sleeve lot #: unknown.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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00769 screw, 0001822565 - 2019 - 04570 stem, 0001822565 - 2019 - 04571 head, 0001822565 - 2019 - 04572 liner, 0001822565 - 2019 - 04573 sleeve.

Event Description

Initial right total hip arthroplasty performed and subsequently underwent revision seven years later of the head and liner due to complications from trunnionosis.The patient underwent a second nine years post initial due to pain, wound complications, and radiolucency with apparent acetabular screw fracture on x-ray.Prior to the revision, the patient underwent a venogram with stenting of the right external iliac vein due to the loose shell occluding the vein.During the revision, the acetabular component was noted to be grossly loose and freely floating within the joint space.Additionally, three soft tissue suture abscesses were noted and excised.The head, liner, and shell were replaced and antibiotic cement beads were placed within the joint.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.D11: 00625006540, bone screw, lot no.61013586.00786201350, femoral stem, lot no.07886766.Unknown ceramic head, lot no unknown.Unknown liner, lot no unknown.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Revision op notes identified patient revised on due to pain, swelling, and elevated chromium levels.During the revision procedure, a significant pseudotumor with surrounding tissue damage and necrosis from trunnionosis was debrided.The stem and shell remained intact, and the head and liner were replaced.Medical notes identified patient was revised due to pain, wound complications, shell loosening and radiolucency with apparent acetabular screw fracture.Lucency around acetabular component with rotation, significant lucency is seen along the acetabular screw.Fractured superior right acetabular screw.Lucency around the proximal aspect of the femoral component with bone formation and surrounding soft tissues which could be heterotopic bone formation (unconfirmed).Abnormal appearance of the right hip prosthesis suggesting loosening.Prosthesis in place that appears to be compressing the external iliac vein, massive edema of the leg.Aseptic loosening rule out possible sepsis.Ebl 850ml, prbcs infused.Severe thickened fibrous tissue noted, partial deskeletonization of the proximal femur (eto) necessary to gain access.Acetabulum too excoriated with too many cavities for good fixation of the acetabular component.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.

• Brand Name: SHELL POROUS WITH CLUSTER HOLES 54 MM O.D.
• 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: 9232802
• MDR Text Key: 163919368
• Report Number: 0002648920-2019-00763
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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: 06/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 00620005422
• Device Lot Number: 61008584
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 78