MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-128
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	01/30/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding pain involving an metal head was reported.The event was not confirmed.Method & results: device evaluation could not be performed as the subject device was not returned.Medical records received and evaluation: a review of the primary and revision operative notes and office clinical notes by the consulting clinician indicated "[.] on (b)(6) 2011 a left total hip arthroplasty was performed.[.]the labels from the chart indicate a 54 trident psl ha cluster shell, a #9 rejuvenate modular stem, a 34mm rejuvenate modular neck, a 28/0 c-taper lfit head, a restoration adm x3 28/52 insert, and a 46mm mdm liner.It should be noted the labels indicate a v-40 taper on the rejuvenate neck and a c-taper head were utilized." "there is no description of revision surgery findings, no examination of the explanted components, and no x-rays to review in this case."the disassociation of the prosthetic femoral head was due to a c-taper head being placed on a v-40 taper, as noted in the prosthetic labels.There is no evidence that factors of faulty prosthetic design, manufacturing, or materials were responsible for this clinical situation." device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event and the root cause could not be determined.Review of the medical records by the consulting clinician indicated "there is no description of revision surgery findings, no examination of the explanted components, and no x-rays to review in this case." if devices and / or additional information become available, this investigation will be reopened.
Event or Problem Description
"a follow-up for his left hip on (b)(6) 2013 noted he complained of pain and stiffness.Physical examination noted the left leg was.5 centimeters shorter.He was ambulating without devices or a limp.A discussion was had regarding, "unsure of etiology of loss of motion and recurrent pain as components appear well-fixed and well-placed".

• Brand Name: 28MM STD LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8293726
• Report Number: 0002249697-2019-00413
• Device Sequence Number: 2018045
• Product Code: JDI
• UDI-Device Identifier: 07613327013023
• UDI-Public: 07613327013023
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 6260-9-128
• Device Lot Number: 39289105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Weight: 98