MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6276-1-025

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978); Material Torqued (2980)

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

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Cone body was placed and impacted properly onto conical stem.Locking bolt was placed through top of cone body and was noted based on shoulder of bolt that cone body was in proper position.Bolt was then tightened with t-handle then proceeded to use torque wrench to tighten to appropriate setting based on needle on instrument.Upon performing this action the bolt sheared at the max.Torque position at approximately the tread location on bolt.The surgeon opted to leave construct in place and close.

Manufacturer Narrative

An event regarding crack/fracture involving a restoration modular bolt was reported.The event was confirmed following visual inspection.Device evaluation and results:visual inspection: the bolt was observed to be fractured.Only the upper section of the fractured bolt was returned.Review of device with material analyst engineer indicated: "fracture located on threading of bolt consistent with overload condition." medical records received and evaluation: a medical review was not performed because no information was provided.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: review of device with material analyst engineer indicated: "fracture located on threading of bolt consistent with overload condition." if further information / device becomes available, this investigation will be re-opened.

Event Description

Cone body was placed and impacted properly onto conical stem.Locking bolt was placed through top of cone body and was noted based on shoulder of bolt that cone body was in proper position.Bolt was then tightened with t-handle then proceeded to use torque wrench to tighten to appropriate setting based on needle on instrument.Upon performing this action the bolt sheared at the max.Torque position at approximately the thread location on bolt.The surgeon opted to leave construct in place and close.

• Brand Name: 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025
• 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: 6158942
• MDR Text Key: 62377319
• Report Number: 0002249697-2016-03881
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2017

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: 01/31/2021
• Device Catalogue Number: 6276-1-025
• Device Lot Number: 53902701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2016
• 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: 56 YR
• Patient Weight: 79