MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 50 MM O.D.; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: cat#650-1158, delta cer fem hd 28/0mm t1, lot#3033285; cat#51-103130, tprlc 133 t1 pps so 13x146mmtp, lot#6644276; cat#00500105028, liner 28 mm i.D.For use with 50/51/52 mm o.D.Shells, lot#64845995.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported the patient underwent left total hip arthroplasty due to femoral neck fracture approximately 7 weeks ago.Subsequently, patient was revised 2 days later due to an iatrogenic acetabular fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was admitted due to a fall and subsequent left femoral neck fracture and anterior column fracture.Due to patient's active life style, they chose to pursue the total hip arthroplasty.Findings were consistent with preoperative images, with significant poor bone quality in the acetabulum.There was loss of fixation of the acetabular cup due to intraoperative bone loss.While reaming, 1cm of soft tissue was found and was reamed to 47, with a 48 cup selected.The cup was implanted but rotated and surgeon didn't think the screws would secure so the cup size was increased multiple times while still unsatisfied.Surgeon then chose a tm cup 52 and placed 2 screws.Once the liner was placed the construct completely rotated and thus removed.Medial wall and anterior inferior wall felt in discontinuity, with no gross instability between the anterior and posterior walls, so x-ray's were ordered.A stem was placed as reasonable femoral bone quality was noted.Due to the acetabulum bone quality issues, instability of acetabulum, and bone loss, it was elected to switch to the hemiarthroplasty to maintain space in length of soft tissues with expectation for revision at some point.Then attempted to place an endo polar head, but it was not compatible with the stem and did not fit, so it was changed to a bipolar head.Surgery was completed and radiographs show disruption of iliopectineal line and no clear disruption of the ilioischial line.While the patient was still admitted at the hospital, they were revised due to an iatrogenic acetabular fracture.A 2nd hip hemiarthroplasty was attempted and failed with medical wall ischial fractures.A total hip revision of both acetabular and femoral components was performed without difficulty.There was a significant posterior wall comminution along the ischial comminution, which was the source of the inability to place the cup.Tm cup and screws were placed, but images revealed to be medialized.They were removed to be repositioned, and no cortical rim fit given the lack of posterior wall due to the continual widening/displacement when trying to place a cup previously.4 screws were placed in the ilium and good alignment was noted.A liner was cemented and the femur was cabled to stabilize and prevent fractures, to which none occurred.Rom was completed and no impingement, with good rom.Surgeon noted the 15 high offset taperloc placed with 40+0 head was the best construct for the patient.No complications noted.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

Event Description

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

• Brand Name: SHELL 50 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: 11949780
• MDR Text Key: 256515681
• Report Number: 0002648920-2021-00148
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00889024115422
• UDI-Public: (01)00889024115422(17)310208(10)64840738
• Combination Product (y/n): N
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00500105000
• Device Lot Number: 64840738
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 63