MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MULTIHOLE II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121720052
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646)
Date of Event	12/09/2011
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.- litigation alleges: in 2002, patient was implanted with a depuy pinnacle mom implant in her right hip.Patient suffered debilitating pain, swelling, inflammation, infection, damage to surrounding bone and tissue, and lack of mobility.In (b)(6) 2005, patient was revised and implanted with a new pinnacle mom device.In 2010, the new implant began slipping out of the socket causing intense pain, discomfort, and the inability to walk without assistance.Patient is unable to be revised a second time due to too little bone structure remaining.Doi: 2002 - dor: (b)(4) 2005 (right hip; first implantation); doi: (b)(6) 2005 - dor: none (right hip; second implantation).Patient is a resident of (b)(6).Update: 11/15/2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified.Originally implanted (b)(6) 2002 revised (b)(6) 2005 because of instability.Records are available for further review.Update ad 27 june 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what was previously reported, ppf alleges loosening of the cup, dislocation with open and closed reduction, infection, loosening of the stem, elevated metal ions, and fracture component after the first revision.The patient harm and patient name were updated and added product experience code and lawyer.Stem, cup, five screws and the unknown hip implant were added to the impacted product due to the alleges loosening, infection and fractured component from the ppf.The first revision was captured under (b)(4).Doi: (b)(6) 2005; dor: none reported (right hip) second revision.(b)(4) (right hip) first revision; (b)(4) (right hip) second revision.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE MULTIHOLE II CUP 52MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8243931
• Report Number: 1818910-2019-80754
• Device Sequence Number: 1912435
• Product Code: LPH
• UDI-Device Identifier: 10603295009627
• UDI-Public: 10603295009627
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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: 121720052
• Device Lot Number: WN4A21002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 01/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 68