MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121722052

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 04/04/2014

Event Type  Injury  

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.Initial reporter occupation: non-healthcare professional "attorney".(b)(4).

Event Description

Litigation alleges that the patient suffers from pain, discomfort, and toxic cobalt-chromium metal debris in tissue and surrounding the implants.Litigation also alleges grinding and squeaking.Update ppf reported acetabular cup and femoral stem loosening (at bone to implant interfaces).

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 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.H10 additional 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.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 Description

Complaint description: new etq record created in order to update etq (legal system) complaint number wpc (b)(4).Reason for original complaint.Litigation alleges that the patient suffers from pain, discomfort, and toxic cobalt-chromium metal debris in tissue and surrounding the implants.Litigation also alleges grinding and squeaking.Update 12/7/2012: medical records were received from legal.Part/lot information was identified.Records are available on external hard drive if needed for further review.Update 3/1/2017: pfs and medical records received./ | investigation method: medical records reviewed 28 mar 2017, kab.From a medical perspective, based on the very limited information available, it is not possible to determine if the complaint is product related.See attached report.Investigation summary:.

• Brand Name: PINNACLE SECTOR II CUP 52MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8277353
• MDR Text Key: 134082325
• Report Number: 1818910-2019-82247
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295009825
• UDI-Public: 10603295009825
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Catalogue Number: 121722052
• Device Lot Number: AW1HA1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 66