MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MOD PLASMA HA STM 19MM X 127MMRESTORATION MODULAR HIP SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6276-5-019

Device Problems Patient-Device Incompatibility (2682); Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During hip arthroplasty revision surgery, the doctor use 18*127 die trial performed operations, and then use 18*127 mod plasma ha stm add to medullary space.The mod plasma ha stm gone down.The doctor decided use 19*127 mod plasma ha stm, this one can't put into the medullary cavity.At last, the doctor use 18*167 mod plasma ha stm finished surgery.The doctor very skeptical about size of "18*127" and "19"*127" mod plasma ha stm.The size of 18*127 mod plasma ha stm doesn't match 18*127 die trial.On (b)(6) 2015: it was confirmed that stryker devices were not revised during the surgery.

Manufacturer Narrative

An event regarding size/fit issue involving a restoration modular stem was reported.The event was not confirmed.Method and results: device evaluation and results: the returned devices were unremarkable.A dimensional inspection was performed.All features conformed to the required specifications with no evidence of a dimensional issue.Medical records received and evaluation: a review of the provided information by a clinical consultant concluded that: an adverse mix of patient-related factors regarding presence of bony defect conditions prior to revision and procedure-related factors regarding optimal component choice and surgical technique for reconstruction during the procedure have resulted in problems with stability of the initially implanted shorter stem combination requiring exchange for longer devices and thereby causing a time delay.End result of reconstruction appears very adequate.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 review of the provided information by a clinical consultant concluded, "an adverse mix of patient-related factors regarding presence of bony defect conditions prior to revision and procedure-related factors regarding optimal component choice and surgical technique for reconstruction during the procedure have resulted in problems with stability of the initially implanted shorter stem combination requiring exchange for longer devices and thereby causing a time delay." consultation with subject matter experts was performed when completing the dimensional inspection for the returned device.All features conformed to the required specifications.No further investigation is required at this time.If further information becomes available this investigation will be re-opened.

Event Description

During hip arthroplasty revision surgery, the doctor use 18*127 die trial performed operations, and then use 18*127 mod plasma ha stm add to medullary space.The mod plasma ha stm gone down.The doctor decided use 19*127 mod plasma ha stm, this one can¿t put into the medullary cavity.At last, the doctor use 18*167 mod plasma ha stm finished surgery.The doctor very skeptical about size of ¿18*127¿and ¿19*127¿ mod plasma ha stm.The size of 18*127 mod plasma ha stm doesn¿t match 18*127 die trial.On (b)(6) 2015: it was confirmed that stryker devices were not revised during the surgery.

• Brand Name: MOD PLASMA HA STM 19MM X 127MMRESTORATION MODULAR HIP SYSTEM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5313992
• MDR Text Key: 34759106
• Report Number: 0002249697-2015-04381
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

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: 06/30/2017
• Device Catalogue Number: 6276-5-019
• Device Lot Number: 40278001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2012
• 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: 42 YR
• Patient Weight: 85