MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 100 HA ACET CUP 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121711058
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Complaint description from etq: 1217-11-058 x1 pinnacle acetabular shell 100 series (lot: 311131) was implanted as per surgical technique.Subsequently, surgeon attempted to screw in (1246-03-000) apex hole eliminator (lot: d13033399) into acetabular shell.However, the apex hole eliminator could not screw into threads of acetabular shell.Therefore, a second apex hole eliminator (lot: d13050493) was opened.This too could not be implanted.The surgeon then said, although he had never had this issue in his multiple prior cases, the threads of the acetabular shell must have been burred.The surgeon decided to not worry about using a hole eliminator and subsequently implanted a shell liner, as per surgical technique.The operation was completed with no further problems.
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: the acetabular cup associated with this report was not received for examination.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.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 100 HA ACET CUP 58MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8746153
• Report Number: 1818910-2019-97197
• Device Sequence Number: 1341980
• Product Code: LPH
• UDI-Device Identifier: 10603295009092
• UDI-Public: 10603295009092
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121711058
• Device Lot Number: 311131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1