MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 7 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6721-0737

Device Problems Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Per sales rep, when the surgeon opened the hip stem and pulled it out of the sleeve he discovered white fuzz on it.Total hip - left.

Manufacturer Narrative

An event regarding foreign material involving a accolade stem was reported.The event was confirmed.Method and results: -device evaluation and results: a visual inspection was carried out on the returned device the part was decontaminated resulting in the foreign material initially reported not being present.However a photo was provided of when the event was identified which shows the foreign material on the device hence confirming the event.The device was otherwise unremarkable.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-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 events for the reported lot.The fibre has been shown to come from sigma and ecocloth wipes used in production.

Event Description

Per sales rep, when the surgeon opened the hip stem and pulled it out of the sleeve he discovered white fuzz on it.Total hip - left.

• Brand Name: SIZE 7 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6138233
• MDR Text Key: 61502907
• Report Number: 0002249697-2016-03794
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153345
• 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: 04/05/2017

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 Expiration Date: 08/31/2021
• Device Catalogue Number: 6721-0737
• Device Lot Number: 56463008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• 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: 62 YR