MAUDE Adverse Event Report: ZIMMER GMBH DURASUL, ALPHA INSERT, LL/36

Model Number N/A

Device Problem Failure to Align (2522)

Patient Problem No Information (3190)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device 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).The actual device reported, is not marketed in usa, but devices with similar characteristics (dural alpha insert neutr gg/32) are marketed in usa, and therefore this report was filed.

Event Description

It was reported that it was not possible to fix a 58 inlay in the cup.During the sample repositioning of the stem, the inlay came out from the cup.After that a new 58 inlay was inserted, without any complication.Surgery was delay for 30 min.

Manufacturer Narrative

Trend analysis: no trend considering the following event is identified: insert did not fit in to cup.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event description (event details, per): event summary: a durasul alpha insert (ref: 01.00013.712 lot: 2915804) has been received.It was reported that the inlay could not be fixed (could still be turned) in the shell within the first two attempts.Then the insert seemed to be fixed, nevertheless, during sample reposition of the stem the inlay again disassembled from the cup.Further, it was very difficult to remove the insert, as sample head and inlay were in situ.After insert removal a new inlay of the same size was inserted, without any complication.Devices analysis: visual examination: the durasul alpha insert shows multiple scratches and dents on the outside area of the inlay.The guidance peg shows deformation.Further imprints from the impaction instrument can be seen on the rim area.On the outer surface of the insert, the two dents normally caused by the two pins of the shell (to ensure rotational stability) are not clearly visible.Only multiple light marks can be found on the outer surface of the insert.Within the insert no damage can be detected.Measurements: to ensure the insert has correct dimensions, relevant characteristic according to the inspection plan were measured: conclusion: the size ll/36 of the insert can be confirmed.Further the dhr indicates that all components met all specifications.Review of product documentation: compatibility: no compatibility check can be performed as only one product has been reported.Inspection plan: characteristic no.11 feature ¿diameter ( 52.37 0.05/-0.05 ): inspection with first lot.Means of inspection: ¿3d measuring machine¿.Characteristic no.16 feature ¿diameter ( 52.69 0.05/-0.05 ): aql 1.0.Means of inspection: ¿3d measuring machine¿.Characteristic no.17 feature ¿diameter ( 52.63 0.05/-0.05 ): aql 1.0.Means of inspection: ¿3d measuring machine¿.The surgical technique describes the alignment/insertion of the insert.It is stated that the peg of the polyethylene liner must be inserted into the pole plug hole prior to impaction.Root cause analysis: root cause determination using dfmea: deformation of the insert (due to load) due to ovalisation of shell, not possible: as no ovalisation of the shell was reported and a second inlay of the same size was inserted without any complications.Failure of connection between shell and insert due to insufficient snap geometry, not possible: a systematic issue with design (snap geometry) would have been detected as part of the issue evaluation assessment.Damage of the insert (cause: impaction during implantation) due to high load due to impaction during primary implantation or revision, possible: as the guidance peg is deformed and the rim shows imprints due to the impactor instrument, a high load during primary implantation can be assumed.The significant dents and scratches on the outer surface of the insert were most likely caused during removal of the insert.Difficulties to assemble insert due to high load due to impaction during the primary implantation or revision leading to damage of the polar plug, not possible: nothing indicates the polar plug has been damaged.Difficulties to assemble insert due to high load due to impaction during the primary implantation or revision leading to damage of the polar thread of the shell, not possible: nothing indicates the polar thread of the shell has been damaged.Difficulties to assemble insert due to high load due to impaction during the primary implantation or revision leading to fracture of the pelvis, not possible: no pelvis fracture is reported.Failure of connection between shell and insert due to wrong pairing of components (wrong size), not possible: as no wrong pairing has been reported and the second inlay of the same size was inserted without any complications.However, the size of the shell cannot be confirmed, as the size of the shell was not reported.Wrong combination of the components due to engraving is not readable under or lighting, marking parameters are not sufficient, not possible: as engraving is still readable and no wrong pairing has been reported.Additionally, the second inlay of the same size was inserted without any complications.Failure of connection between shell and insert (wrong pairing) due to wrong selection of parts due to unknown compatibility list, not possible: as no wrong pairing has been reported and the second inlay of the same size was inserted without any complications.However, the size of the shell cannot be confirmed, as the size of the shell was not reported.Failure of connection between shell and insert due to wrong assembly procedure, possible: as the guidance peg is deformed and several light spike marks are present, it can be assumed that the guidance peg of the inlay was not properly centered to the polar plug before impaction.Insufficient insert stability in shell short and long term due to surgeon does not comply to surgical technique (early stability), possible: as the guidance peg is deformed and several light spike marks are present, it can be assumed that the guidance peg of the inlay was not properly centered to the polar plug before impaction.According to the surgeon the insert could still turn after impaction, which confirms insufficient stability.Conclusion summary: based on the returned product and the given information the complaint could be confirmed.The returned insert with size ll/36 has been produced according to specifications and its correct size can be confirmed.A possible root cause: the multiple light dents caused by the two pins of the shell and the deformed guidance peg of the inlay indicate that the inlay was slightly tilted before impaction.It seems that the surgeon had difficulties with centering the insert within the shell prior to impaction, which led to the deformation of the peg during impaction, making it subsequently even more difficult to achieve a correct position and an anchoring of the inlay.On the outer surface of the insert, the two dents normally caused by the two pins of the shell (to ensure rotational stability) are not clearly visible.Only multiple light marks can be found on the outer surface of the insert which shows that the insert never reached its intended final position at the bottom of the shell.However, based on the returned product and the given information an exact root cause could not be determined.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).

• Brand Name: DURASUL, ALPHA INSERT, LL/36
• Type of Device: DURASUL, ALPHA INSERT, LL/36
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7074045
• MDR Text Key: 93422403
• Report Number: 0009613350-2017-01682
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 01.00013.712
• Device Lot Number: 2915804
• Other Device ID Number: 00889024413658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 107