MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ALLOFT-S ALLOCLASSIC SHL 50/HH

Model Number N/A

Device Problems Mechanical Problem (1384); Fitting Problem (2183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2021

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.The manufacturer received other source of 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, after the shell was implanted the liner was found unable to match the shell.The shell was removed and a new shell and a liner were used to complete the surgery.The replacement of implants resulted in 30 minute extension of operation time.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: d9, h2, h6.Correction: b4, g3, g6, h10.Event description: it was reported that during surgery on (b)(6) 2021, the insert could not be placed in the shell.The shell was removed and a new shell and liner were used to complete the procedure.The replacement of the implants resulted in a surgical delay of 30 minutes.Review of received data: no medical data relevant to the case has been received.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 shell and the insert have been returned for examination.The rim of the shell has some nicks and the thread is worn.Otherwise, the part is inconspicuous.The pole peg has been cut off of the insert and is indented and deformed.On the outside, there are two pronounced indentations from the pins of the shell, evenly distributed on both sides of the peg.In addition, many other lighter indentations can be seen.Further, the rim of the insert shows scratches and indentations.Measurements: to ensure the insert has correct dimensions, relevant characteristics according to inspection plan sap document no.3003 rev.15 and product drawing 063.225.301 rev.00 were measured with caliper.Characteristic no.2 feature diameter 44.69 +0.05/-0.05 -measured value: 44.72 mm characteristic no.3 feature diameter 44.37 +0.05/-0.05 -measured value: 44.34 mm charcteristic no.21 feature height of inlay 15.5 +0.05/-0.05 -measured value: 15.45 mm characteristic no.43 feature diameter 41.6 +0.3/-0.3 - measured value: 41.62 mm conclusion: the measured characteristics of the snap feature are within specification.Pin: charcteristic no.45 feature height 4 +0.1/-0.1 -measured value: 3.24 mm charcteristic no.51 feature diameter 4.6 +0.01/-0.01 -measured value: 5.14 mm conclusion: the pin has been cut off.The characteristics of the pin are not within specification as the pin is deformed and damaged.To ensure the shell has correct dimensions, relevant characteristics according to inspection plan and product drawing were measured with caliper.Characteristic no.16 feature diameter 48 +0.3/-0.3 -measured value: 48.04 mm characteristic no.18 feature dimension 23.518 +0.2/-0.2 -measured value: 23.57 mm characteristic no.51 feature dimension 4 +0.05/-0.05 -measured value: 4.04 mm characteristic no.53 feature diameter 44.535 +0.015/-0.015 -measured value: 44.53 mm - conclusion: the measured characteristics are within specification.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr: no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that during surgery on (b)(6) 2021, the insert could not be placed in the shell.The shell was removed and a new shell and liner were used to complete the procedure.The replacement of the implants resulted in a surgical delay of 30 minutes.The quality records show that all specified characteristics of the shell and the insert have met the specifications valid at the time of production.The measurements showed that the characteristics relevant to the assembly of the allofit shell and the durasul alpha insert were within the predefined specifications (with the exception of the cut off pole peg, which is indented and deformed).Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The multiple impressions of the shell's pins on the outer surface of the insert indicate that the insert was placed and impacted multiple times.The deformation of the cut off pole peg indicates that the insert was not perfectly centered in the shell during impaction.Further, cutting off the pole peg is not approved by zimmer biomet and is classified as an off-label use.The scratches and nicks on the rim of the insert and on the shell can be attributed to their removal.Therefore, the most likely cause of the reported assembly issue is insufficient centering of the insert in the shell during insert impaction.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: ALLOFT-S ALLOCLASSIC SHL 50/HH
• Type of Device: ALLOFT-S ALLOCLASSIC SHL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11265617
• MDR Text Key: 229826741
• Report Number: 0009613350-2021-00048
• Device Sequence Number: 1
• Product Code: JDI
• 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: 08/10/2021

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: 4264
• Device Lot Number: 3011751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 50