MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-442

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems Fall (1848); Pain (1994); Injury (2348)

Event Date 12/29/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient walked across square, tripped and fended off the fall by left leg.In this motion felt pain whereby patient believed the prosthesis had subluxated.The incidence is reported without fall trauma.Patient crawled to side walk and received help from there, was taken to emergency care.X ray showed fractured neck of hip prosthesis exeter.Revision surgery was then performed.A new exeter short stem was inserted through cem in cem technique.X rays available.Patient in otherwise good health, (b)(6) male in full health and plays golf a lot on spare time.Received exeter-marathon prosthesis in 2003.Patient (b)(6).Date of primary surgery (b)(6) 2003; date of fracture (b)(6) 2016; date of revision (b)(6) 2016.

Manufacturer Narrative

An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed following visual inspection.Method & results: -device evaluation and results: visual inspection was carried out as part of the material analysis report dated february 27, 2017.The report noted: "the returned device was examined with the aid of a stereo microscope at magnifications up to 50x.The damages consistent with explantation and cement-mantle breakdown were observed on the stem.Post-fracture abrasion was observed on the fracture surfaces examined.A material analysis has been performed.The report concluded: the stem fractured due to fatigue.Eds showed the stem was consistent (b)(4).No material or manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: a review by a clinical consultant noted: "the most frequent cause of such a neck fracture is component malposition leading to impingement, usually cup malposition.Although there is a suggestion about cup malposition in neutral version, this cannot really be proven with enough certainty due to at first lack of a lateral x-ray.Often cup anteversion can be calculated from the oval index of the cup opening circle on the ap view (arcsine of smallest/largest diameter) but such requires clear cup landmarks.This case has a poly cup with only partial wire marker, further shielded from view by the ceramic head and consequently such calculations would be rather inaccurate in this patient.There are translations of the original (b)(6) surgical records that do not document any relevant issues with the arthroplasty prior to fracture.The patient stumbled and came to a fall during the event but this does not necessarily mean that a fall was the contributing overload factor.With device fractures, the reverse usually happens, at first the stem neck fractures and subsequently the patient comes to a fall.Of relevance may be that the exeter stem was combined with a non stryker cup.The primary surgical report documents that a depuy made charnley ogee cup was implanted, probably a 53-mm/28-mm type because not explicitly referred by size but surgical reaming was up to 54-mm and a 53-mm is the largest available.The next smaller size would be a 50-mm.The poly is a cross-link called marathon.No other procedure-related matters are evident form the available info to potentially contribute to overload and/or fatigue build-up although a strong suspicion remains about the possibility of cup malposition in suboptimal anteversion.Without a proper lateral x-ray this can however not be proven with an acceptable level of evidence.Consequently this case cannot be solved with the current information.A proper lateral x-ray prior to or post revision (the cup was retained) would be the most helpful item to help solve this case." -device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusions: a review by a clinical consultant concluded: "no other procedure-related matters are evident form the available info to potentially contribute to overload and/or fatigue build-up although a strong suspicion remains about the possibility of cup malposition in suboptimal anteversion.Without a proper lateral x-ray this can however not be proven with an acceptable level of evidence.Consequently this case cannot be solved with the current information.A proper lateral x-ray prior to or post revision (the cup was retained) would be the most helpful item to help solve this case." if additional information becomes available, this investigation will be reopened.

Event Description

Patient walked across square, tripped and fended off the fall by left leg.In this motion felt pain whereby patient believed the prosthesis had subluxated.The incidence is reported without fall trauma.Patient crawled to side walk and received help from there, was taken to emergency care.X ray showed fractured neck of hip prosthesis exeter.Revision surgery was then performed.A new exeter short stem was inserted through cem in cem technique.X rays available.Patient in otherwise good health, (b)(6) male in full health and plays golf a lot on spare time.Received exeter-marathon prosthesis in 2003.(b)(6).Date of primary surgery (b)(6) 2003.Date of fracture (b)(6) 2016.Date of revision (b)(6) 2016.

• Brand Name: EXETER V40 STEM 44MM NO 2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6309383
• MDR Text Key: 66762746
• Report Number: 0002249697-2017-00489
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0580-1-442
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 124