MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, HOODED, HH/32; NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER

Model Number N/A

Device Problems Difficult to Insert (1316); Nonstandard Device (1420)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  Death  

Manufacturer Narrative

The manufacturer received the device on jun 02,2021.X-rays and other documents were received and will be reviewed as part of ongoing investigation.Lot numbers were received and the device history records were reviewed and found to be conforming.The investigation of the case and the process of gaining necessary information is still ongoing.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

Event happened during a surgery on (b)(6) 2021.It was noticed that the liner would not fit into the allofit cup.The surgery was completed with another bigger cup with a surgical delay of 60 min.

Event Description

Investigation has been completed.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that three different inserts could not be placed in the allofit shell during a primary hip implantation on (b)(6) 2021.Therefore, a larger size 52 allofit shell with a new insert was implanted.Due to the assembly issue, there was a surgical delay of 60 minutes.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.X-rays: the received radiographs of the right hip were received with no information relevant to the case.Surgical report: please note that the medical records have been translated from dutch into english.Surgical report from (b)(6) 2021: postoperative diagnosis: coxarthrosis treatment: right uncemented total hip replacement via direct superior approach description of procedure: opening of the joint.There is coxarthrosis.Detachment of the acetabulum with resection of labrum and soft tissue.Reaming up to 50mm with offset reamers.Insertion of a trial cup of the same size.This cup has a good hold.Insertion of the definitive cup 50mm, paying attention to the correct anteversion and inclination angle.The pe insert is inserted and checked.It is loose.Try again, again no grip.Removing the centering peg, again no grip.Check again for impingement of tissue, which is not present.Repositioning is again unsuccessful.New liner again no grip.Contact biomet/zimmer.First remove screw, again no fixation.We decide to try 1 more insert, but again no grip.We decide to remove the cup and ream up to 52mm and place a new cup.When placing the 52/il insert we have a good fixation at the first attempt.Implantation of the femoral components.Closure.Other medical records do not contain additional relevant information to the case.Product evaluation: visual examination: the reported allofit shell 50/hh and the three reported durasul alpha inserts hh/32 were received for examination.Ref: 01.00013.508, lot: 3050071, without peg: the inner articulation surface and the rim have some light scratches, but are otherwise inconspicuous.The outer rim, especially at the hooded side has some indents.The polar peg has been cut off.On both sides of the polar peg there are multiple indents (approx.4) from the shells' anti-rotation pins, which are not perfectly evenly distributed on both sides of the polar peg, indicating that the insert was not perfectly centred during impaction.Ref: 01.00013.508, lot: 3050071, with peg: aside from a few scratches, the inner and outer surfaces of the insert are unremarkable.The polar peg is still intact and there are 2 imprints from the shell's anti-rotation pins, which are almost evenly distributed on both sides of the polar peg.Ref: 01.00013.508, lot: 3050070, with peg: the inner articulation surface and the rim have some light scratches, but are otherwise inconspicuous.The outer rim, especially at the hooded side has some indents.The polar peg is indented on one side and the multiple imprints on both sides of the polar peg are not perfectly evenly distributed on both.Ref: 4244, lot 3057988 the allofit shell has some bone remains on the outer surface.The inner and outer surfaces appear unremarkable.The thread is slightly worn but the returned polar screw, which is also worn, can still be screwed in.Measurements: to ensure that the inserts have correct dimensions, relevant characteristics according to inspection plan sand product drawing were measured with caliper.Ref: 01.00013.508, lot: 3050071, without peg: the measured diameters were within the defined specification.To ensure that the shell has correct dimensions, relevant characteristics according to inspection plan and product drawing were measured with caliper.The measured diameter is within the defined specification.The measured height is within the defined specification.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no relevant deviations or anomalies during manufacturing.Conclusion: it was reported that three different inserts could not be placed in the allofit shell during a primary hip implantation on (b)(6) 2021.Therefore, a larger size 52 allofit shell with a new insert was implanted.Due to the assembly issue, there was a surgical delay of 60 minutes.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).The measurements showed that the dimensions of the devices received were within the given specifications.Visual inspection of two inserts indicates that the inserts were not perfectly centred during impaction.One insert looks inconspicuous because the imprints from the shell anti-rotation pins are evenly distributed on both sides of the still intact polar peg.Since the surgeon reports that a possible interference with soft tissue was checked before insert impaction, it can be assumed that interference with soft tissue did not lead to the assembly issue.However, it is possible that the shell was slightly deformed during insertion into the acetabulum, due to inaccurate preparation of the acetabulum or due to interference with bone or soft tissue remnants between the acetabulum and the allofit shell.However, based on the documentation received and examination of the devices, no definitive cause could be determined.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).The following reports are associated with this event: 0009613350-2021-00290-1, 0009613350-2021-00287-1.

• Brand Name: DURASUL, ALPHA INSERT, HOODED, HH/32
• Type of Device: NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12007863
• MDR Text Key: 256444337
• Report Number: 0009613350-2021-00291
• Device Sequence Number: 1
• Product Code: LZO
• 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: 10/22/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.508
• Device Lot Number: 3050070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization