MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, HOODED, HH/32

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 07/04/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: unknown; catalog#: unknown; lot#: 300418.Durasul, alpha insert, hh/28; catalog#: 0100013208 ; lot#: 3026966.Unknown; catalog#: unknown ; lot#: 6378029.Micro taprlc std pc 10mm 12/14; catalog#: 6500954; lot#: 6726002.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.(b)(4).

Event Description

During surgery the liner would not lock into the shell.The procedure was completed using a different liner.

Event Description

Investigation result is available.

Manufacturer Narrative

Event description: it was reported that during surgery the liner would not lock into the shell.The procedure was completed using a different liner.Product evaluation: visual examination: the complained durasul alpha liner was returned for investigation.Articulation side: the rim shows some scratches and imprints from the liner setting instrument and a cut in one area.Further the articulation surface is inconspicuous.Backside: the centralizing liner pole pin is cut off.There are some nonconcentric indentations of the shell's anti-rotation spikes the indentations are also unevenly pronounced.Further, some signs of wear in a stripe all around the lateral surface of the rim along the proximal edge (edge closer to the pole) are visible.Based on the visual examination the reported event can be confirmed.Measurements: to ensure the durasul alpha inlay hooded 32/hh have correct dimensions, relevant characteristics according were measured: characteristic no.3 feature diameter 44.37 +0.05/-0.05.Specification: max.44.42 mm; min.44.32 mm.Measured value: 44.35 mm.Conclusion: the characteristic is within specification.Characteristic no.43 feature diameter 41.6 +0.3/-0.3.Specification: max.41.9 mm; min.41.3 mm.Measured value: 41.65 mm.Conclusion: the characteristic is within specification.Characteristic no.2 feature diameter 44.69 +0.05/-0.05.Specification: max.44.74 mm; min.44.64 mm.Measured value: 44.71 mm.Conclusion: the characteristic of the upper snap diameter is within specification.Characteristic no.21 feature height of inlay 15.5 +0.05/-0.05.Specification: max.15.55 mm; min.15.45 mm.Measured value: 15.53 mm.Conclusion: the characteristic of the height is not within specification.The pin could not be measured as it has been cut off.Review of product documentation: device purpose: this device is intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.The surgical technique states: 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.If the fitting of the insert is faulty, a new insert must be used.If the polar peg is deformed, it will not be possible to anchor the insert correctly.Note: if unsure, the seating can be checked using a raspatory.If the fitting of the liner is faulty, a new insert must be used.If the polar peg is deformed, it will not be possible to anchor the liner correctly.Conclusion: it was reported that during surgery the liner would not lock into the shell.The procedure was completed using a different liner.Based on the investigation the reported event can be confirmed.The detected damages / imperfections on the returned insert indicate that the liner was mispositioned, nonconcentric or interfered with soft tissue residues.It is possible that remains of tissue and/or inappropriate alignment of the inlays prior or during impaction prevented the inlays from snapping into position.Further, cutting off the pole pin of the inlays is considered an off-label use, as the durasul alpha inlay must not be altered in any way.The pole pin is an essential design feature for centralizing and stabilizing the inlay inside the allofit shell.Nevertheless, based on the investigation and the available information, we were not able to identify an exact root cause for the reported assembly issue.However, this is a common complication also described in the applicable surgical technique of the allofit acetabular system.This complication requires the use of a new liner, which has been applied correctly.The investigation did not identify a nonconformance or a complaint out of box (coob).

• Brand Name: DURASUL, ALPHA INSERT, HOODED, HH/32
• Type of Device: DURASUL, ALPHA INSERT, HOODED
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10288548
• MDR Text Key: 199991707
• Report Number: 0009613350-2020-00328
• 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: 12/21/2020

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: 01.00013.508
• Device Lot Number: 3018083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/21/2020
• 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