MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 56MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121703056
Medical Device Problem Codes	Osseointegration Problem (3003); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646)
Date of Event	07/11/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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 etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint.- patient was revised to address pain.Doi 2009; dor (b)(6) 2012; (left hip).Update 7/16/12 - litigation papers were received.There is no new information that would affect the investigation.Update: 10/31/2012 pfs was received from legal, medical records were received from legal.Records indicate that the patient was revised because of pain and metallosis.There is no new information that would change the existing mdr decision.Records are available for further review.Update rec'd 2/12/2014- pfs and medical records received.After review of the revision operative note there is no new additional information that would affect the existing mdr decision.The complaint was updated on: 03/10/14.Additional information: doi: (b)(6) 2009; dor: (b)(6) 2012; (left hip).12/9/14 update patient harms and/or complaint category nr.Update ad 29 may 2018: (b)(4) has been reopened under (b)(4) due to receipt of pff and sticker sheets.In addition to what were previously alleged, pff alleges infection requiring antibiotics, metal wear and metallosis confirmed in the medical records.It is also being alleged that the cup and stem were loose; however, previously reported medical records did not indicate any loosening of the cup and stem.The stem, cup and hole eliminator are being reported due to alleged infection but were not revised.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
Udi: (b)(4).
Event or Problem Description
Ppf alleges loosening of the stem and cup.
Additional Manufacturer Narrative
(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 300 ACET CUP 56MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7645738
• Report Number: 1818910-2018-63429
• Device Sequence Number: 2281652
• Product Code: LPH
• UDI-Device Identifier: 10603295008675
• UDI-Public: 10603295008675
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/25/2018

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 Catalogue Number: 121703056
• Device Lot Number: DL8DN1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 12/04/2018; 06/21/2019
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 09/13/2018; 12/11/2018; 06/21/2019
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 125