MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ2 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157001080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Test Result (2695); No Code Available (3191)
Date of Event	03/15/2013
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.Concomitant medical products: delta cer head 12/14 32mm +5 hip femoral head; altrx neut 32idx48od hip acetabular liner; pinn 100 w/gription 48mm hip acetabular cup; summit por taper sz2 std off hip femoral stem; apex hole elim positive stop acetabular hole eliminator.Initial reporter occupation: non-healthcare professional ¿ attorney.(b)(4).
Event or Problem Description
Patient was revised to address instability.Update ad (b)(6) 2018 in addition to what was previously alleged, ppf alleges elevated metal ions.Doi: (b)(6) 2012; dor: (b)(6) 2013; (left hip).
Event or Problem Description
Patient was revised to address instability.Update 1/28/15 - disc 209 pfs and medical records received.Pfs alleges patient suffers from pain.Pfs identified patient dob, height and weight.The head is now being reported and a liner is being added.Doi (b)(6) 2012 - dor (b)(6) 2013 (left hip).Update ad 1 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.In addition to what was previously alleged, ppf alleges elevated metal ions.Added stem due to this allegation.Facility name, associated contact, head and liner expiration date were also added.Doi: (b)(6) 2012 - dor: (b)(6) 2013 (left hip).Patient is bilateral.Please see (b)(4) for right hip.
Additional 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.Product complaint # (b)(4).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.

• Brand Name: SUMMIT POR TAPER SZ2 STD OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8077232
• Report Number: 1818910-2018-75701
• Device Sequence Number: 1527448
• Product Code: LPH
• UDI-Device Identifier: 10603295059332
• UDI-Public: 10603295059332
• 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: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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 Expiration Date: 11/30/2019
• Device Catalogue Number: 157001080
• Device Lot Number: D52B71
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/11/2019
• 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: 49 YR
• Patient Weight: 63