MAUDE Adverse Event Report: ZIMMER GMBH ALLOFIT® ALLOCLASSIC®, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 58/LL; ALLOFIT ACETABULAR SYSTEM

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device reported in section d is not marketed in usa, but devices with similar characteristics (i.E allofit alloclassic shell 62(nn) are marketed in usa, and therefore this report was filed.Where lot numbers were received for the device(s), the device history record 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

It is reported that a surgeon tried to implant a allofit® alloclassic®,shell with polar screw plug, uncemented, 58/ll on (b)(6) 2016 in a patient on the left hip side.During impact of the durasul-pe with the original setting instrument into the allofit cup , both metal spikes of the cup loosened from the inner side in the pole area.The cup had to be changed and therefor the surgery was delayed for 30 minutes.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Review of event description: - event summary: it was reported that during the impaction of durasul pe with the original setting instrument into the allofit cup, both metal spikes loosened from the inner side and came off.There was no direct contact between the instrument and the spikes during impaction process.Due to spike loosening there was no rotationally stable impact of the pe-inlay possible.Therefore the implanted cup had to be removed from acetabulum.Consequently, 30 min extension of the surgery happened.Review of received data: - one intraoperative imaging was received in which the acetabular cup is seen to be positioned in the patient's acetabulum.Devices analysis: visual examination: allofit® alloclassic®, 58/ll (ref:4248, lot:2858157) and durasul®, alpha insert, ll/36 (ref: 01.00013.712 lot: 2851632) were received for the investigation.The front surface of the insert exhibits couple of scratches at the rim.No damage can be seen on the articulating surface.The anchoring surface of the insert is seen to have two slight indents most probably due to the contact with the spikes of the metallic shell.The indents appear to be not paired and not in symmetry with the center of the insert.The metallic shell was returned with the two spikes detached from itself.The anchoring surface of the shell is observed to have some scratches.Slight deformation is visible at the bore holes due to the loosening of the spikes.Except those, no other deformation is noticed within the inner surface, some bone remnants are visible at the outer surface of the shell confirming that the shell was positioned in the acetabulum.The bore holes within the anchoring surface of the metallic shell where the spikes are attached via a deforming process (bulging) have been checked macroscopically in order to see if there is any problem related to the dimensions.No abnormalities observed regarding the appearance.Moreover, the respective gages are inserted into the holes and it is observed that there was no difficulty in inserting the gages even with the larger sides of them, which could mean that the hole dimensions are larger than the expected values.However, no further comments can be made regarding this due to the deformation presence at the bore hole entrance.In order to see if this issue applies to other items from the same batch, the only article left under zimmer biomet control from the same lot (2858157) was returned to zimmer (b)(4) for analysis.Device analysis showed that the spikes cannot be loosened in any way of strong force applied.The item is confirmed to be conforming.Based on this fact and having no complaint received from the respective lot 2858157, it can be said that the issue does not apply to the batch in general.Review of product documentation: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Review of inspection plan: - characteristic no.41, feature ¿bore diameter¿, by visual inspection aql 2.5.Means of inspection: grenzlehrdorn.Seven (7) out of 50 pieces were inspected.- characteristic no.42 feature ¿tiefe der spikes¿ by qualitative inspection aql 2.5.Means of inspection: tiefenmessschieber.Thirteen (13) out of 50 pieces were inspected.- characteristic no.79 feature "bis zum anschlag ein- gepresst und durch aufstauchen gesichert" by 100% qualitative inspection with gage, quantitative inspection aql 0.65, automated inspection aql 1.0.Means of inspection: visual.Fifty (50) out of 50 pieces were inspected.Conclusion summary: the fixation of the spikes in the bore holes has been considered to not meet the requirements according to the investigation output.The review of the dhr indicates that the devices met all requirements to perform as intended after being manufactured.No design issue is present.The inspection results were according to specifications.If the spikes had already loosened or fallen out during manufacturing process, this would have been detected during 100% visual final inspection.A complaint query taking all the product families with the same spike manufacturing process into consideration was performed.It showed that there was one other similar complaint received in the timeframe of the respective market entrance of the products.The probability of occurrence of harm for this event (spike loosening) was calculated as 0.00047%.The risk for this event is found to be in the acceptable range according to our risk management procedure.According to the analysis of the information available at hand, the root cause of the event is considered as manufacturing issue.However, based on the investigation results and very low probability of harm/occurrence, zimmer (b)(4) considers the risk of the reported event as acceptable.No further action is deemed necessary.Should any further similar events be reported, possible actions can be taken into consideration.(b)(4).

• Brand Name: ALLOFIT® ALLOCLASSIC®, SHELL WITH POLAR SCREW PLUG, UNCEMENTED, 58/LL
• Type of Device: ALLOFIT ACETABULAR SYSTEM
• 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: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6124164
• MDR Text Key: 60761192
• Report Number: 0009613350-2016-01372
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/28/2016

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 4248
• Device Lot Number: 2858157
• Other Device ID Number: 00889024166059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• 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): Other
• Patient Age: 69 YR