MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-03-052
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Pain (1994); Burning Sensation (2146); No Code Available (3191)
Date of Event	06/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 etq record created in order to update etq (legal system) complaint number (b)(4).Reason for original complaint ¿ litigation papers allege the patient was revised due to implant failure.Update rec'd 5/12/2014 - amended litigation papers received.Original litigation indicated that the patient was implanted with asr; however, amended litigation alleges that the patient was implanted with pinnacle.The products have been updated and follow-ups created.In addition to what was previously reported, litigation alleges the patient suffers from damage to her hip joints and body.A doi has been provided and litigation indicated it is for the left hip.Update - pfs and medical records received.After review of the medical records for mdr reportability, the part/lot numbers were updated.Litigation papers allege the patient had pain and a lump and that "the top of implant needs replaced".At the time of this review there was no mention of lumps or need for revision in the medical documents provided and no revisions listed.The complaint was updated on:(b)(6) 2015.Update 6/30/2016 - patient was revised due to pain.Removed head and liner.There is no new information that would affect the existing mdr decision complaint was updated (b)(6) 2016.Update ad 09 oct 2015: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metal wear, metallosis and elevated metal ions.Added law firm, account name, surgeon and an impacted product record for the stem was added due to alleged elevated metal ions.Doi: (b)(6) 2004 - dor: (b)(6) 2016 (left 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.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Per nr-0134037 a medical record review is not required for this complaint record investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 will be filed as appropriate.

• Brand Name: PINNACLE 300 ACET 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: 9916077
• Report Number: 1818910-2020-09992
• Device Sequence Number: 19437079
• Product Code: LPH
• UDI-Device Identifier: 10603295008651
• UDI-Public: 10603295008651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2015

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: 1217-03-052
• Device Catalogue Number: 121703052
• Device Lot Number: X5AE41000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/09/2020; 04/09/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/21/2020; 05/04/2020
• 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: 71 YR
• Patient Weight: 58