MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 27MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-027; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6276-1-027

Device Problems Break (1069); Detachment Of Device Component (1104); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Revision hip procedure, patient had a cement spacer insitu from a previous infection.Spacer removed and a restoration modular performed.During the case after the stem being inserted, the surgeon (erak) had difficulty threading the cone reamer post onto stem, and attaching the trial cone body.While inserting the cone body implant the locking screw tip broke off into the top of the stem.Surgeon removed cone body implant, attempted to remove remaining screw without success.Surgeon then left the screw tip insitu and used a new cone body implant, without using a screw to secure version.

Manufacturer Narrative

Corrected data: the device was not returned for evaluation.An event regarding crack/fracture involving a restoration modular bolt was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a medical review was performed and concluded: "issues with adequate alignment of straight instruments in a curved femoral bone, possibly further contributed by local bone problems after previous infection, quite likely caused an oblique connection between proximal rm body and distal stem.Tightening the locking bolt in such an oblique direction contributed to an acute overload condition on the locking bolt causing a bending fracture with all the problems as reported as result." 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 medical review was performed and concluded that "tightening the locking bolt in such an oblique direction contributed to an acute overload condition on the locking bolt causing a bending fracture with all the problems as reported as result." no evidence of a device related issue was identified through the review.Further information however including return of the device is needed to fully investigate.No further investigation is required at this time.If further information / device becomes available, this investigation will be re-opened.Not returned.

Event Description

Revision hip procedure, patient had a cement spacer insitu from a previous infection.Spacer removed and a restoration modular performed.During the case after the stem being inserted, the surgeon (erak) had difficulty threading the cone reamer post onto stem, and attaching the trial cone body.While inserting the cone body implant the locking screw tip broke off into the top of the stem.Surgeon removed cone body implant, attempted to remove remaining screw without success.Surgeon then left the screw tip insitu and used a new cone body implant, without using a screw to secure version.

• Brand Name: 27MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-027
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5676477
• MDR Text Key: 46202412
• Report Number: 0002249697-2016-01693
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/27/2016

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: 12/31/2017
• Device Catalogue Number: 6276-1-027
• Device Lot Number: 42140101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2012
• 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: 84 YR
• Patient Weight: 90