MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 21MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-221; IMPLANT

Catalog Number 6276-1-221

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/03/2015

Event Type  Injury  

Event Description

Revising a restoration modular to lengthen the leg.Original restoration modular was implanted on (b)(6) 2013.Surgeon attempted to separate the body from the stem using the 6278-9-070 body/stem separator, lot tace913.The tip of this broke off inside the cone body.Surgeon was able to remove broken pieces from inside the cone body using forceps.Surgeon then attempted to remove entire construct using 6260-4-090 mcreynolds distal stem adaptor lot tacl506, on the slap hammer.The thread of the mcreynolds distal stem adaptor snapped off inside the implant.Surgeon then decided to leave stem insitu and change head to 36mm +10 (item 6260-9-336 lot mlaw5e) to give extra length.Important to note, cone body screw could not be re-inserted as thread from distal stem adaptor was still stuck inside implant.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(6).The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.

Event Description

Revising a restoration modular to lengthen the leg.Original restoration modular was implanted on 9/9/2013.Surgeon attempted to separate the body from the stem using the 6278-9-070 body/stem separator, lot tace913.The tip of this broke off inside the cone body.Surgeon was able to remove broken pieces from inside the cone body using forceps.Surgeon then attempted to remove entire construct using 6260-4-090 mcreynolds distal stem adaptor lot tacl506, on the slap hammer.The thread of the mcreynolds distal stem adaptor snapped off inside the implant.Surgeon then decided to leave stem insitu and change head to 36mm +10 (item 6260-9-336 lot mlaw5e) to give extra length.Important to note, cone body screw could not be re-inserted as thread from distal stem adaptor was still stuck inside implant.

• Brand Name: 21MM MOD REV HIP BDY/BLT +20MMCOMPONENT LEVEL 9006-1-221
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4874502
• MDR Text Key: 22160168
• Report Number: 0002249697-2015-02127
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: 07/31/2018
• Device Catalogue Number: 6276-1-221
• Device Lot Number: 44009502
• Other Device ID Number: STERILE LOT# 1309REM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2013
• 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): Required Intervention
• Patient Age: 62 YR