MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ5 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157002110
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Pocket Erosion (2013); Swelling (2091); Tissue Damage (2104); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
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.Occupation: attorney.
Event or Problem Description
Litigation papers allege that the patient has suffered pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, pseudotumours, bursitis, and bone erosion.Patient is a resident of (b)(6).Update ad 4 may 2018: receipt of ppf and sticker sheets.In addition to what was previously reported, ppf alleges metal wear.Metallosis and elevated metal ions.Patient harm, unknown liner and the unknown head were updated and added product code, lot number, patient date of birth, and the side of the hip.Stem was added to the impacted product due to the alleged elevated metal ions from the ppf.Doi: (b)(6) 2003; dor: none reported; (left hip).
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.

• Brand Name: SUMMIT DUOFIX TAP SZ5 STD 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: 8300997
• Report Number: 1818910-2019-83082
• Device Sequence Number: 59256
• Product Code: LPH
• UDI-Device Identifier: 10603295059462
• UDI-Public: 10603295059462
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: 157002110
• Device Lot Number: XK3AD1007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1