MAUDE Adverse Event Report: ZIMMER GMBH MS-30, LATERAL STEM, CEMENTED, 6, TAPER 12/14; MS-30 LATERAL FEMORAL STEM

Model Number N/A

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer received the device for investigation on december 21, 2016.The investigation is pending.Surgery reports, photographs and x-rays have been received.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.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted a ms-30, lateral stem, cemented, 6, taper 12/14 on (b)(6) 2003.The patient underwent a revision surgery on (b)(6) 2016 due to breakage of the stem.

Manufacturer Narrative

The manufacturer received the device for investigation on (b)(6) 2016 the investigation is pending.Surgery reports, photographs and x-rays have been received.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.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted a ms-30, lateral stem, cemented, 6, taper 12/14 on (b)(6) 2003.The patient underwent a revision surgery on (b)(6) 2016 due to breakage of the stem.The surgery was delayed for about 1hr 10min for removal of the well fixed stem tip through a diaphyseal window and following osteosynthesis.No contributing conditions like trauma or injury.

Manufacturer Narrative

Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event description: it was reported that a patient was implanted with an ms-30 stem on (b)(6) 2003 on the right hip side and underwent revision surgery on (b)(6) 2016 due to implant fracture.Review of received data: surgical report of implantation, dated (b)(6) 2003.The report was received in (b)(6), translated to english and the main points are summarized below: indication: clinically and radiologically progressive coxarthrosis of the right hip.Procedure: a lateral approach is used.The ventral capsule is exposed and opened.Serous effusion drains.There is significant synovitis.The ventral capsule and the labrum are resected; the acetabulum is prepared with the reamers up to size 54.A trial cup is inserted which has a very good hold.A fitmore cup is impacted which shows a very firm hold.A polyethylene insert with metasul inlay is placed.The proximal part of the femur is prepared with the ms-30 instrumentation.In very narrow conditions only one reamer of size 6 can be used.A trial prosthesis is inserted and reduction with a medium head is made.There is a bit too little muscle tension, so it is decided to use a head with a long neck for the definitive implantation.A size 10 absorbable medullary plug is placed.The femur is dried with a tampon and a ms-30 stem, size 6, is cemented.After the complete hardening of the cement reduction is made to check the muscle tension.A metasul head with a long neck is mounted.A functional test shows good stability without tendency for dislocation.Extensive rinsing is performed, redon drainages are inserted and the wound is closed.An x-ray check is made.Surgical report of revision, dated (b)(6) 2016.The report was received in (b)(6), translated to english and the main points are summarized below: diagnosis: stem loosening with suspicion of osteolysis on the right hip with metal pairing in situ.Indication: massive pain when moving and loading the right hip.Radiologically, clear stem loosening and proximal osteolysis is observed.Change of the inlay due to the metal pairing.There is no evidence for pseudotumor or metal reaction.Procedure: the joint is opened through the old scar, the neocapsule is resected and the acetabulum exposed.There is no noteworthy metal reaction.The prosthesis can be dislocated without problems.After a few hammer strikes, the stem can be removed without problems.It is observed that approximately 3 cm of the stem (distal portion) remain in situ, thus a stem fracture is present.This was not recognizable on all the diagnostic imaging.The acetabulum is exposed, the inlay is removed and a new one is inserted.An x-ray is made and the height of the stem¿s tip is determined.A second incision with a length of 4 cm is made and the femur is exposed.Four drill holes are made and a bone flap is lifted directly above the cement which is partially removed with the chisel.Under image intensifier the bone window is extended to proximal until the tip of the stem becomes visible.Using an instrument, space is created until the fragment can be moved in cranial direction.After several manipulations it is finally possible to retrieve the stem fragment.From the proximal side, the remaining proximal cement in the area of the osteolysis is removed.Scraping of the osteolysis and extensive rinsing is performed.Under image intensifier and using the bone window the cement mantle is drilled out in order to create space for a larger implant.The femur is further prepared by rasping and drilling, and the final implant size is chosen.Creating the bone window and removal of the cement plug beyond the intended depth, resulted in a weakening of the femur at the level of the prosthesis tip.Therefore, it is decided to perform a protective osteosynthesis.A 6-hole large plate is placed.An image intensifier check shows a correct position of the plate.After extensive rinsing the definitive components are cemented.The cement excess is removed.At the bone window it is found that some cement has escaped which contributes to the stability and is left as it is.After rinsing the wound is closed.A final image intensifier check shows the correct position of the implant and plate.Additional information from the hospital: an email received on (b)(6) 2017 informs about the height and weight of the patient.A trauma or an accident is not stated in the anamnesis.X-rays: two image-intensifier ap x-rays taken during implantation on (b)(6) 2003 were received.It can be observed that the stem is implanted in varus position.A pelvis ap view taken on (b)(6) 2016 shows the situation after the revision surgery.Devices analysis - visual examination: the ms-30 stem is fractured approximately one third above its tip.In this region the laser marking is located on the medial side.With the exception of a small area in the middle, both fracture surfaces are polished.On the proximal fracture surface several scratches can be seen, most probably made during revision surgery.At the anterior edge of both fracture surfaces small cracks can be observed.Under certain light conditions, slight matt areas can be recognized on all sides of the stem, on both fracture parts.Investigation of the slight matt areas with the microscope revealed fine scratches and small line- to dot shaped indentations.On the medial side of the proximal fracture part of the stem an area with corrosion can be recognized.On the medial side of both fracture parts the laser marking is partially polished.At the medial edge of both fracture surfaces a small area with corrosion can be observed.Revision damage in the form of coarse scratches can be observed on the stem taper, on the stem¿s neck and shoulder as well as on the stem¿s tip.The face surface of the taper is discolored.Otherwise the taper is inconspicuous.On the articulation surface of the metasul head there are numerous fine and some coarse scratches.The latter can be attributed to the revision surgery.Near the equator, under certain light conditions, a partial borderline between the loaded and unloaded areas is visible.Close to this borderline an area with organic deposits as well as an area with parallel scratches can be seen.The articulation surface was investigated under the microscope (at 200-times magnification with differential interference contrast (dic).As observed visually under certain light conditions, the borderline between the loaded and the unloaded area is well recognizable.In the loaded area fine scratches can be recognized and the carbides, which protruded slightly in the original surface state, are leveled.In the unloaded area the original surface state with slightly protruding carbides is still visible.In a small region of the unloaded area, spots can be observed that could point to cell-induced corrosion.With the exception of a discoloration noticeable in the non-contact area, the head taper is inconspicuous.Conclusion: after approximately 12 years and 10 months in vivo the hip prosthesis was revised due to stem loosening and osteolysis in the proximal femur.During revision surgery a fracture of the ms-30 stem was discovered.The fracture is located approximately one third above the distal end of the stem.As the fracture surfaces are mostly polished the type of fracture and its origin could not be identified.The stem shows slight matt areas on all of its sides and a partially polished laser marking in the area of the fracture.The proximal fracture part of the stem exhibits small line- to dot-shaped indentations.The beforehand described phenomena indicate a loosening between the implant and the cement.However, without a complete x-ray follow-up the situation of the stem and how it changed over time in vivo remains unknown.The reason for the loosening that probably contributed to the fracture is unknown.According to the surgical report of revision the metasul insert was also revised but not sent for investigation.Therefore, only the metasul head as part of the metal on metal pairing could be investigated.The articulation surface of the head did not show special phenomena and the wear value does not seem to be elevated.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.Zimmer biomet's reference number is (b)(4).

• Brand Name: MS-30, LATERAL STEM, CEMENTED, 6, TAPER 12/14
• Type of Device: MS-30 LATERAL FEMORAL STEM
• 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: 6215540
• MDR Text Key: 63633587
• Report Number: 0009613350-2016-01513
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 12/09/2016

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: Lay User/Patient
• Device Expiration Date: 11/15/2006
• Device Model Number: N/A
• Device Catalogue Number: 01.00351.001
• Device Lot Number: 2091389
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/01/2017; 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2001
• 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: 84 YR
• Patient Weight: 75