MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DURASUL, ALPHA INSERT, KK/32; ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS

Model Number N/A

Device Problem Component Incompatible (1108)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays for review.Per and product label were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive yet the device, however it is indicated by complainant that it will be returned for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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

During the surgery plug of the inlay couldn't fit into the central locking screw and the cup could not be securely inserted after removing the plug.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that during the surgery the plug of the inlay couldn't fit into the central locking screw and the cup could not be securely inserted after removing the plug.The surgery was completed with another device.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 complained durasul alpha liner was returned for investigation.The articulation side shows very slight circular imprint possibly deriving from the setting instrument.Further, the articulation surface looks inconspicuous.The backside shows a cut off pole plug and non-centrical indentations of the shell's anti-rotation spikes.The proximal edge of the rim is damaged and slightly crushed and on the opposite side there is wear on the spherical area close to the rim.Furthermore, there is signs of wear around the lateral surface of the rim.- measurements: to ensure the durasul alpha inlay 32/kk have correct dimensions, relevant characteristics were measured with caliper.Characteristic no.11 feature diameter 50.37 +0.05/-0.05: -specification: max.50.42 mm; min.50.32 mm; -measured value: 50.30 mm (measured next to the damage).Characteristic no.15 feature diameter 47.6 +0.3/-0.3: -specification: max.47.9 mm; min.47.3 mm; -measured value: 47.61 mm.Characteristic no.16 feature diameter 50.69 +0.05/-0.05: -specification: max.50.74 mm; min.50.64 mm; -measured value: 50.70 mm.Charcteristic no.21 feature height of inlay 18.5 +0.05/-0.05: -specification: max.18.55 mm; min.18.45 mm; -measured value: 18.46 mm.The pin could not be measured as it has been cut off.-conclusion: the measured characteristic is within specification.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as only the complained product is known.- 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.- surgical technique liner insertion: if the liner can still be rotated after light impaction, this indicates mispositioning, 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.Conclusion: it was reported that during the surgery the plug of the inlay couldn't fit into the central locking screw and the cup could not be securely inserted after removing the plug.The surgery was completed with another device.Based on the investigation the reported event can be confirmed.The deformation / wear on the durasul alpha liner as well as the cut off pole plug may indicate that the liner was mispositioned, nonconcentric or interfered with soft tissue residues.This is a common complication also described in the applicable surgical technique which requires the use of a new liner.Nevertheless, an exact root cause could not be determined.The investigation did not identify a nonconformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: DURASUL, ALPHA INSERT, KK/32
• Type of Device: ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10816470
• MDR Text Key: 215545658
• Report Number: 0009613350-2020-00535
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K013935
• 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: 02/09/2021

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: 01.00013.411
• Device Lot Number: 3007749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization