MAUDE Adverse Event Report: ZIMMER GMBH PROTASUL, S30 HEAD, S, 28/-4, TAPER 12/14; PROTASUL S30 HEAD

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: protasul, s30 head, s, 28/-4, taper 12/14, catalog no#: 30.28.05, lot no#: 2938245.Original m.E.Muller, stem, pt-s30, 13.75, taper 12/14, catalog no#: 35.0039.137, lot no#: 2944170.Bipolar shell, modular, 52, catalog no#: 61270052, lot no#: unknown.Bipolar insert, modular, 50/28, catalog no#: 61272850, lot no#: unknown.Therapy date : (b)(6) 2018.The manufacturer did 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).

Event Description

Patient was implanted with protasul s-30 heads, could not be made firm on the muller straight stem.The first head was removed.The second head and the shaft remained in-sito.A shaft was removed due to the patient condition.The implantation and explantation dates are left empty as the device involved in this complaint was intra operatively removed.

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: unable to fix the head on the stem.Event summary: according per.Both heads on the stem conus were not fixed enough.The surgeon was able to remove the head just by hand.Surgeon decided to leave the second head on the stem.Removal of the stem was not possible based on the patient's condition.Review of received data intraoperative x-rays were received.They show no anomalies regarding the position of the head and the stem.Surgical report dated (b)(6), 2018: until the positioing of the head on the stem all the steps were without problem.Stem was well fixed and the trial head shown to be optimal.Surgeon felt overall loose connection when she seated the head on the stem.After reconfirming the identification of the implanted stem and head, surgeon decided to implant another new small head but again the situation of the overall loose connection didnt change.First head sent to zimmer for quality check.Intra op photos showed the correct positioining of the dualhead prosthesis.No loosening observed.Devices analysis visual examination: protasul s30 head, s, 28/-4, taper 12/14 (ref: 30.28.05 lot: 2938320) was received for investigation.The head does not shown any imperfection or damages.Functional test with a original m.E.Müller® straight stem, lateral of same taper size and the received metallic head is done and it is seen that when the head is seated on the stem and then rotated afterwards it become quite fixed on the stem.No loose feeling was experienced during the functional test.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.According inspection plan at the time of the production, characteristics were inspected for ms-30 stem cone and protasul s30 head and found to be conforming.Surgical technique for original m.E.Müller® straight stem states on the page 11: "13.After the cement has hardened completely, and the taper has been carefully rinsed, the ball head is mounted.If necessary, a trial reduction is carried out beforehand with the trial head.The head is mounted with a rotatory movement.14.Locking of the head by means of a light hammer blow on the reduction lever." root cause analysis root cause determination using rmw (s30 head): intraoperative complications, components have to be ordered from hospital stock, failure of connection between stem and ball head due to surgeon is unable to assemble head on stem taper (e.G.Due to wrong sizing of components) => possible, in case not following the surgical technique, it is likely to have a not fixed connection.Root cause determination using rmw (ms stem): components have to be ordered from hospital stock due to surgeon is unable to assemble and/or fix the components => possible, surgeon was not able to fix the head and ordered the second head.- unable to assemble head on stem taper (impingement prior to proper taper fit) due to inadequate design of taper connection (between stem and head) not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.- disassembling of parts due to insufficient insertion force => possible, in case of insufficient force applied on the head, it is likely to have a not fixed connection.Conclusion summary according the event surgery was delayed by 15 min due to surgeon feeling a loose connection between the head and the stem upon insertion of the head on the stem taper.Review of the device history records for the products did not identify any deviations or anomalies related to the reported event.They show that all of the devices were inspected at the time of production according the inspection plan with 100% scope of inspection in terms of the related features.Functional test with the stem and head show proper fixed connection of the head-stem is possible to achieve with a rotational movement of the head upon seating on the stem.Therefore, the head is considered to have no problem in relation to the reported failure.Proper assembly of the head on the stem is explained in the surgical technique of the stem.Most likely reason for the reported event is assumed to be not rotating the head upon seating / insufficient force applied by the surgeon during the assembly of the head on the stem.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

Patient was implanted with protasul s-30 heads, could not be made firm on the muller straight stem.The first head was removed.The second head and the shaft remained in-sito.A shaft removal was, due to the condition of the patient, not possible.

• Brand Name: PROTASUL, S30 HEAD, S, 28/-4, TAPER 12/14
• Type of Device: PROTASUL S30 HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7640693
• MDR Text Key: 112750693
• Report Number: 0009613350-2018-00652
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: PN/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: 10/19/2018

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 Model Number: N/A
• Device Catalogue Number: 30.28.05
• Device Lot Number: 2938320
• Other Device ID Number: 00889024163980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 38 YR