MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 300 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121703054
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	11/28/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 extremely high ion levels.Doi: (b)(6) 2007 - dor: (b)(6) 2011 (right hip).Update: 10/17/2012 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 06 jun 2018: (b)(4) has been re-opened under (b)(4) due to ppf and sticker sheet record received.Ppf alleges loosening of cup and elevated metal ions.Added lawyer name, law firm name, expiration date, udi and patient harm.Added cup in the ip records due to loosening of the cup however, it was not revised.Corrected manufacturing date head, liner and revision hospital.Doi: (b)(6) 2007: dor: (b)(6) 2011; right hip.
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.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 54MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8134258
• Report Number: 1818910-2018-77294
• Device Sequence Number: 1672658
• Product Code: LPH
• UDI-Device Identifier: 10603295008668
• UDI-Public: 10603295008668
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2018

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: 121703054
• Device Lot Number: A11E91000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 05/08/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 12/05/2018; 05/08/2019
• 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: 47 YR
• Patient Weight: 103