MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, II/36; HIP PROSTHESIS

Model Number N/A

Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.Medical products: allofit alloclassic, shell with polar screw plug, uncemented, 52/ii; catalog#: 4245; lot#: 3058009.Fitmore, hip stem, uncemented, offset b (extended)/5, taper 12/14; catalog#:01.00551.305; lot#:3035739.Biolox delta, ceramic femoral head, l, 32/+3.5, taper 12/14; catalog#:00-8775-032-03; lot#:3052967.Durasul, alpha insert, ii/32; catalog#: 01.00013.409; lot#: 3028084.Therapy date: unknown.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that during surgery after placing the acetabular component several attempts were made to place the liner but the liner would not lock.The procedure was completed using another liner.

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported that during surgery after placing the acetabular attempts were made to place the liner but the liner would not lock.Review of received data: due diligence: no further "due diligence" required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: the visual examination confirms the reported event; it shows that insert has scratches, nicks and indentations on the surface.It has a deformed and indented pole peg, as well as deformations.In addition, three pin imprints are visible, which most likely is from the anti-rotation pins of the shell.The articulation surface has some scratches, but are otherwise inconspicuous.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Surgical technique: "position the liner over the entrance plane of the shell and rotate clockwise.The peg of the polyethylene liner must be inserted into the pole plug hole.Complete seating of the liner with a light hammer blow.If the liner can still be rotated after light impaction, this indicates mispositionning, nonconcentric, or soft tissues interference between the liner and the shell surfaces.In such situation, remove the liner, clean both surfaces and introduce the liner back into the shell, making sure it is properly centered and repeat the seating procedure.Once the liner remains steady after light hammer blows, finalize seating with final impaction." conclusion: it was reported that during surgery after placing the acetabular attempts were made to place the liner but the liner would not lock.The visual examination revealed that the pole peg of the insert is damaged it can be assumed that the insert was in a slightly inclined position when it was impacted.Moreover, it is also possible that the pole plug was not aligned or not screwed entirely into the apical hole leading to reduced total depth for liner to seat in.Other possible cause that contribute to the difficulty of liner insertion includes presence of soft tissue or debris between shell and insert.Based on the investigation the reported event can be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).In conclusion, it is assumed that the insert was in a slightly tilted position within the shell prior or during impaction leading to the assembly issue.However, it is unknown to which extent each of the mentioned factors might have played a role in the slightly tilted position leading to the reported event.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.Investigation results are now available.

• Brand Name: DURASUL, ALPHA INSERT, II/36
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11736788
• MDR Text Key: 250037314
• Report Number: 0009613350-2021-00188
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.709
• Device Lot Number: 3039037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 07/30/2021
• 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