MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PINNACLE SECTOR II CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722054

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104); Inadequate Osseointegration (2646); Not Applicable (3189)

Event Date 01/16/2009

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.- the patient was revised because of infection.Possibly alval, metal-on-metal reaction.Doi: (b)(6) 2007; dor: (b)(6) 2009; (right side).Update 09/28/2011 litigation paper received, there is no new information that would change the outcome of this investigation.Update: 10/23/2012 pfs was received from legal, medical records were received from legal.There is no new information that would change the existing mdr decision.Records are available for further review.Update ad 21 may 2018: (b)(4) has been reopened under (b)(4) due to receipt of ppf record.In addition in what was previous alleged.Ppf alleges loosening of cup.Added cup and hole eliminator due to allegation.

Manufacturer Narrative

Product complaint #
=
> pc-(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE SECTOR II CUP 54MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7619355
• MDR Text Key: 111667114
• Report Number: 1818910-2018-62651
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295009832
• UDI-Public: 10603295009832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 121722054
• Device Lot Number: B3KB11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2018
• Date Device Manufactured: 09/04/2007
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 82