MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 62MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-01-062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526)
Date of Event	09/24/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
New unity record created in order to update etq complaint number (b)(4).Litigation alleges that the patient suffers from pain, discomfort, inflammation, and large amounts of toxic cobalt chromium metal ion particles to be released into the blood, tissue, and bone.Update rec'd 1/10/2014 ¿ pfs and medical records received.Part/lot was provided.Original litigation mentioned issues from metal on metal; however, the sticker sheet indicates that the patient was actually implanted with poly and ceramic.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 2/4/2014 update ad 01 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.There were no new allegation and revision reported.Added stem due to previously alleged large amounts of toxic cobalt chromium metal ion.Added lawyer in the associated contact.Update ad 16 jul 2021.Pfs and medical records received.Pfs alleges pain, swelling, snapping, and clunking sound.Pfs also indicated that the patient is using cane and wheelchair.Doi: (b)(6) 2010 - dor: none reported (right hip).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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: PINNACLE 100 ACET CUP 62MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12306343
• Report Number: 1818910-2021-17555
• Device Sequence Number: 4785507
• Product Code: LPH
• UDI-Device Identifier: 10603295008606
• UDI-Public: 10603295008606
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 09/26/2013

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 Model Number: 1217-01-062
• Device Catalogue Number: 121701062
• Device Lot Number: E2AJM1000
• 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: 07/21/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2010
• 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: ALTRX +4 NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 12; DELTA CER HEAD 12/14 36MM +1.5; PINNACLE 100 ACET CUP 54MM; ALTRX +4 NEUT 36IDX54OD; APEX HOLE ELIM POSITIVE STOP; CORAIL2 STD SIZE 12; DELTA CER HEAD 12/14 36MM +1.5; PINNACLE 100 ACET CUP 54MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 93 KG