MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157011120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).E3 initial reporter occupation: lawyer.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Litigation alleges patient experienced severe pain and discomfort, and difficulty walking, and performing activities of daily living.Doi: (b)(6) 2007 - dor: none reported (right hip).Update 12/26/2012- pfs and medical records were received from legal.Part/lot information was identified.There is no new information that would change the existing mdr decision.Records are available for further review.Age and middle initial added.Update ad 29 june 2018: wpc 14940-2012 has been re-opened under (b)(64 due to the receipt of ppf and sticker sheets.Ppf has no allegation and revision reported.A lawyer was added.The patient underwent bilateral total hip arthroplasty the left hip was captured under (b)(4).Doi: (b)(6) 2007.Dor: none reported (right hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, ¿litigation alleges patient experienced severe pain and discomfort, and difficulty walking, and performing activities of daily living.Doi: (b)(6) 2007 - dor: none reported (right hip) patient is a resident of al update 12/26/2012- pfs and medical records were received from legal.Part/lot information was identified.There is no new information that would change the existing mdr decision.Records are available for further review.Age and middle initial added.Update ad 29 june 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.Ppf has no allegation and revision reported.A lawyer was added.The patient underwent bilateral total hip arthroplasty the left hip was captured under (b)(4).¿ the product was not returned to depuy synthes, however photos were provided for review.(b)(4).Visual analysis of the photo revealed that there was no damage or defects with the summit por taper sz6 hi off.Photo/x-ray revealed there was not any detected failure and/or malfunction which could affect proper functionality when required.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the summit por taper sz6 hi off was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.

• Brand Name: SUMMIT POR TAPER SZ6 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17965781
• Report Number: 1818910-2023-21373
• Device Sequence Number: 20772096
• Product Code: LPH
• UDI-Device Identifier: 10603295060079
• UDI-Public: 10603295060079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 05/29/2017
• Device Catalogue Number: 157011120
• Device Lot Number: BV9F31000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE M HEAD 36MM +1.5; PINNACLE MTL INS NEUT36IDX50OD; SUMMIT POR TAPER SZ6 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female