MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-11-080
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Discomfort (2330); Injury (2348); No Code Available (3191)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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
Doi:(b)(6) 2006 dor: none reported (unk side).Update: 8/31/2012 litigation papers received alleging that the patient had severe pain and discomfort.Litigation pending that the patient had pinnacle products not asr.(right hip).Update 1/14/2013 - pfs was received from legal, medical records were received from legal, and part/lot information was identified.Records are available for further review.Update ad 29 jun 2018: wpc 3278-2012 has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.Ppf alleges metal wear metallosis.Added lawyer in associated contact, surgeon, account name, law firm, updated date of revision, updated patient harm and manufactured date in product details.Corrected patient identifier.Doi: (b)(6) 2006 - dor: (b)(6) 2017 (right hip).

• Brand Name: SUMMIT POR TAPER SZ2 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9702233
• Report Number: 1818910-2020-04683
• Device Sequence Number: 16833231
• Product Code: LPH
• UDI-Device Identifier: 10603295060031
• UDI-Public: 10603295060031
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2012

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
• Operator of Device: Health Professional
• Device Model Number: 1570-11-080
• Device Catalogue Number: 157011080
• Device Lot Number: Z4KFT1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 02/25/2020
• 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: 60 YR
• Patient Weight: 125