MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-22-058

Device Problem Malposition of Device (2616)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Pain (1994); Rash (2033); Discomfort (2330); Depression (2361); Joint Disorder (2373); Osteolysis (2377); No Code Available (3191)

Event Date 08/30/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges that the patient suffers from damage to his joints and body.Update: 07/15/2013 pfs was received from legal, medical records were received from legal, and part/ lot information was identified by invoice search.Records are available for further review.Corrected: doi: (b)(6) 2009.(right hip); doi: (b)(6) 2009; (left hip).Update ad 27 jul 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.In addition to what were previously alleged, ppf alleges metal wear and metallosis.Added account name, facility name, age, revision date, patient code, associated contacts, products expiration and udi.Corrected patient identifier and event date.Doi: (b)(6) 2009.Dor: (b)(6) 2012, (right hip).Patient is bilateral, please see (b)(4) for the left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : investigative update: 20 / august / 2021.Patient x-ray images have been provided for review.The acetabular cup has been added to this report.No device associated with this report was received for examination.Provided x-ray images are paper copies within patient medical records.That being noted nothing indicative of a product problem is identified.No gross malpositioning can be confirm using these paper copies.No conclusions can be drawn or root cause for the problems reported identified using the provided images.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.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PINNACLE SECTOR II CUP 58MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9880095
• MDR Text Key: 188211890
• Report Number: 1818910-2020-09246
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295009856
• UDI-Public: 10603295009856
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/12/2013

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1217-22-058
• Device Catalogue Number: 121722058
• Device Lot Number: DV5DK1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 101