MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 52MM; HIP ACETABULAR CUP

Catalog Number	121720052
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Injury (2348)
Date of Event	11/15/2017
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
The patient was revised to address hip pain.There was a size 12 collarless corail, with a 36+1.5 metal head, 52 pinnacle sector porous cup, 36x52 mom liner, and 2 screws (not sure length).The op note that i received did not have reference or lot numbers.There were also 3 competitor cable in place from the original surgery.The most proximal cable was remove and appeared to have frayed lose, possibly causing tissue irritation? also, the coral stem seemed to be well fixed so we left the stem and implanted a 36 ceramic ts head.The cup and metal liner were also removed to eliminate any possible metal issues.The surgeon decided to go with a zimmer revision cup and change the cup position slightly.The original cup position did not seem to be out of line.Doi: (b)(6) 2010, dor: (b)(6) 2017.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Device history lot: null.Device history batch: null.Device history review: null.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
In addition to what was previously alleged, litigation alleges friction and wear caused toxic metal ions and particles to be released to the plaintiff¿s blood, tissue and bone surrounding the implant resulting to injury, discomfort, soreness and impaired adl.Added stem.Added new associated contacts.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.Udi: (b)(4).
Event or Problem Description
Ppf alleges pseudotumor, metallosis and elevated metal ions.Added date of birth of patient, product details of cup, head, liner, stem and screws in impacted products.Doi: on (b)(6) 2010, dor: on (b)(6) 2017, left hip.Cn (wipro).
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 SECTOR II CUP 52MM
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 7000 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7107629
• Report Number: 1818910-2017-51260
• Device Sequence Number: 94344
• Product Code: KWA
• UDI-Device Identifier: 10603295009627
• UDI-Public: 10603295009627
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K073504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/16/2019

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: E29DC1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/15/2018; 05/09/2018; 09/16/2019; 12/17/2019
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/23/2018; 05/11/2018; 10/02/2019; 01/14/2020
• 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: 51 YR
• Patient Weight: 71