MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT ALLOCLASSIC SHL 56/KK; ALLOFIT ACETABULAR SYSTEM

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.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

It was reported that a cup did not sit straight on the impactor.A second cup had to be used and implanted to complete surgery.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: impactor doesnot sit straight on cup.Event summary: it has been reported that during surgery the allofit cup did not sit straight on the impactor.A second cup had to be used and implanted to complete the surgery.Review of received data: no medical data such as surgical notes or any other case-relevant documents received.Devices analysis: visual examination: an allofit cup size 56/kk has been returned for an investigation.On the outer surface there are some deformations.On the inner surface there are some scratches around the pole, which are especially concentrated on one half of the sphere.The threads have some signs of usage, but seem functional.Functional test: a functional test has been performed at the hip development department.An allofit straight shell impactor has been screwed on the allofit cup.The threads were found to be functional.It can be confirmed that the cup does not sit straight on the impactor but is inclined.Review of product documentation inspection planning: inspection plan: characteristic "screw thread m8x1" means of inspection: thread plug gauge (gewindelehrdorn).Device history records (dhr): the review of the dhr indicates that the cup met all requirements to perform as intended.The threads of 13 out of 50 manufactured products have been tested.Root cause analysis root cause determination using pfmea: ¿product out of specification¿ is addressed and can have the following root causes: incorrect tool used -not possible, as the threads are functional.Damaged/wrong/broken tool used - not possible, as the threads are functional wrong clamping mechanism used - possible, as this might have led to the inclination of the threads clamping mechanism not centred - possible, as this might have led to the inclination of the threads swarf (span) in clamping mechanism - possible, as this might have led to the inclined clamping of the cup and consequently an inclination of the threads.Conclusion summary: the allofit cup has been returned for an investigation.The functional test confirmed that the cup is inclined when screwed on the impactor.The threads have not been manufactured according to specifications for this cup, but they are inclined.Based on the available information further investigation has been initiated to determine the necessity of potential corrective and/or preventive actions.Product hold has been initiated.The complaint rate was calculated as (b)(4)% and was assessed as acceptable.Based on the available information at this point of time no evidence for a systematic issue was found.As every cup had to be placed one by one on the clamping mechanism, it is assumed that the tilted manufactured thread is a single occurrence.Therefore the issue is assumed to be due to a human error.The manufacturing process for cutting of the thread was changed.A new manufacturing instruction was created on 31.October 2017 and was applied for the first time on 6.December 2017 (after manufacturing of the complained product).According to the manufacturing instruction created on 31.October 2017 the allofit cup is held by a clamping device in its position and is tightened to a plan surface by the clamping mechanism.Only insertion of the parts in the clamping device is carried out manually.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: ALLOFIT ALLOCLASSIC SHL 56/KK
• Type of Device: ALLOFIT ACETABULAR SYSTEM
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7272481
• MDR Text Key: 100427169
• Report Number: 0009613350-2018-00250
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PK003758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

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 Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00000004247
• Device Lot Number: 2929116
• Other Device ID Number: 00889024166042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1