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

Model Number N/A

Device Problems Positioning Failure (1158); Fitting Problem (2183); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Concomitant medical products: durasul alpha insert, ii/36; catalog#: 01.00013.709; lot#: 3043864; allofit alloclassic shell with polar screw plug, uncemented, 52/ii; catalog#: 4245; lot#: 3038703.The manufacturer received per and x-rays 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 biomets reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side.During the second revision surgery an intra-operative complication occurred.The surgeon tried to replace the liner twice with a new one but could not do so to the same cup.Hence, the surgeon revised the cup with a new allofit shell and used a new durasul liner.There was a surgical delay of about 15 minutes.

Event Description

No event update.Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported that during revision surgery on (b)(6) 2021 two new durasul alpha inserts would not seat in the implanted allofit shell.Hence, the allofit shell had to be replaced and a new insert was seated.The replacement caused a surgical delay of 15 minutes.Review of received data: no medical data relevant to the case has been received.Product evaluation: visual examination: the allofit shell and both durasul alpha inserts were returned for examination.The shell is no longer perfectly round, but shows slight deformations.There are scratches and nicks on the shell's inner surface, especially at the rim.The tip of one of the two pins is completely ground off.In addition, on the same side of the abraded pin, from halfway up, the shell's sidewall is abraded and polished.Bone remnants as well as some worn teeth can be seen on the shell's anchoring surface.Both inserts have scratches, nicks and indentations on their surfaces.Both have a deformed and indented pole peg, as well as sheared material.In addition, both inserts have only one pin imprint, which is from the remaining pin of the shell.The articulation surfaces have some scratches, but are otherwise inconspicuous.Measurements: to ensure that the inserts have correct dimensions, relevant characteristics according to inspection plan were measured with caliper z 7568.Durasul alpha insert lot #3046062: characteristic no.11 feature diameter 46.37 +0.05/-0.05.Specification: max.46.42 mm; min.46.32 mm.Measured value: 46.34 mm.The measured diameter is within the defined specification.Characteristic no.16 feature diameter 46.69 +0.05/-0.05.Specification: max.46.74 mm; min.46.64 mm.Measured value: 46.65 mm.The measured diameter is within the defined specification.Characteristic no.31 feature height 16.5 +0.05/-0.05.Specification: max.16.55 mm; min.16.45 mm.Measured value: 16.49 mm.The measured height is within the defined specification.Durasul alpha insert lot #3043864: characteristic no.11 feature diameter 46.37 +0.05/-0.05.Specification: max.46.42 mm; min.46.32 mm.Measured value: 46.42 mm.The measured diameter is within the defined specification.Characteristic no.16 feature diameter 46.69 +0.05/-0.05.Specification: max.46.74 mm; min.46.64 mm.Measured value: 46.69 mm.The measured diameter is within the defined specification.Characteristic no.31 feature height 16.5 +0.05/-0.05.Specification: max.16.55 mm; min.16.45 mm.Measured value: 16.55 mm.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 www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that during revision surgery on (b)(6) 2021 two new durasul alpha inserts would not seat in the implanted allofit shell.Hence, the allofit shell had to be replaced and a new insert was seated.The replacement caused a surgical delay of 15 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 visual examination of the shell revealed that the shell is deformed, has an abraded sidewall and one worn off pin.The damage noted on the inserts, consisting of the deformed pole pegs and sheared material, indicates that the inserts were not properly centered in the shell prior to or during impaction.Based on the investigation, the most likely cause of the assembly issue is the deformed and damaged shell that prevented the inserts from being properly placed.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).

• 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: 11337381
• MDR Text Key: 233568331
• Report Number: 0009613350-2021-00070
• Device Sequence Number: 1
• Product Code: KWY
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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: 3046062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2021
• 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