MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6721-0535

Device Problems Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Mechanical Jam (2983); Positioning Problem (3009); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

The following other devices were also listed in this report: trident hemispherical cluster hole shell; cat# 502-11-50d; lot# 52949401, 32mm std lfit v40 head; cat# 6260-9-132; lot# 53144301, 6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot# vy135m, 6.5 cancellous bone screw 20mm; cat# 2030-6520-1; lot# 8p6hro, trident 0 deg x3 insert 32mm head; cat# 623-00-32d; lot# 53248701.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device remained implanted in the patient and was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.

Event Description

At clinical study 12 month follow-up visit, patient presented with mild thigh pain with postural stiffness.

Manufacturer Narrative

An event regarding pain involving an accolade stem was reported.A medical review by a clinical consultant concluded that the size and position of the stem contributed to this pain.Method & results: -device evaluation and results: not performed as the device was not returned -medical records received and evaluation: a review of the provided medical notes and x-rays by a clinical consultant concluded: procedure-related factors: - stem tip touching inner femoral cortex patient-related factors - none evident device-related factors: - none diagnosis: - accolade stem tip touching inner femoral cortex has quite likely contributed to a local overload condition with thigh pain as outcome.Such complaints are often transitory.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a clinical review concluded : [.]accolade stem tip touching inner femoral cortex has quite likely contributed to a local overload condition with thigh pain as outcome.Such complaints are often transitory.[.] if further information becomes available this investigation will be re-opened.

Event Description

At clinical study 12 month follow-up visit, patient presented with mild thigh pain with postural stiffness.

• Brand Name: SIZE 5 ACCOLADE II 127 DEG
• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6432288
• MDR Text Key: 70801328
• Report Number: 0002249697-2017-01003
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 6721-0535
• Device Lot Number: 52594403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• 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): Other
• Patient Age: 70 YR
• Patient Weight: 89