MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 T1 PPS HO 16X152MM; PROSTHESIS, HIP

Catalog Number 51-104160

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034-2019-02469, 0001825034-2019-02471, 0001825034-2019-02472, 0001825034-2019-02473, 0001825034-2019-02474, 0001825034-2019-02475, 0001825034-2019-02476, 0001825034-2019-02477, 0001825034-2019-02479, 0001825034-2019-02480, 0001825034-2019-02481, 0001825034-2019-02482, 0001825034-2019-02483, 0001825034-2019-02484, 0001825034-2019-02485, 0001825034-2019-02486, 0001825034-2019-02487.Associated device(s): item #: 51-104160, item name: tprlc 133 t1 pps ho 16x152mm, lot number: 3817553, primary di#: (b)(4); 51-104160, tprlc 133 t1 pps ho 16x152mm, 6028661, (b)(4); 51-104140, tprlc 133 t1 pps ho 14x148mm, 3817531, (b)(4); 51-103180, tprlc 133 t1 pps so 18x156mm, 3975978, (b)(4); 51-103180, tprlc 133 t1 pps so 18x156mm, 6022911, (b)(4); 51-103170,tprlc 133 t1 pps so 17x154mm, 6238743, (b)(4); 51-103170, tprlc 133 t1 pps so 17x154mm, 6133628, (b)(4); 51-103160, tprlc 133 t1 pps so 16x152mm, 6309256, (b)(4); 51-103150, tprlc 133 t1 pps so 15x150mm, 6118653, (b)(4); 51-103140, tprlc 133 t1 pps so 14x148mm, 6075801, (b)(4); 51-103140, tprlc 133 t1 pps so 14x148mm, 6170567, (b)(4); 51-103130, tprlc 133 t1 pps so 13x146mmtp, 6308779, (b)(4); 51-103090, tprlc 133 type1 pps so 9x137mm, 6462370, (b)(4); 51-100080, tprlc 133 fp type1 pps so 8.0, 6364712, (b)(4); 51-100060, tprlc 133 fp type1 pps so 6.0, 6289409, (b)(4); 51-100060, tprlc 133 fp type1 pps so 6.0, 6273744, (b)(4); 51-100050, tprlc 133 fp type1 pps so 5.0, 6241443, (b)(4); 51-100040, tprlc 133 fp type1 pps so 4.0, 6246127, not released.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the device packaging had damage that compromised sterility.No patient or surgical involvement as the issue was identified in the inventory warehouse.No further information is available at this time.

Manufacturer Narrative

It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.

Event Description

It was determined this device did not cause or contribute to a reportable malfunction, serious injury, or adverse event.Please void this submission.

• Brand Name: TPRLC 133 T1 PPS HO 16X152MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8678941
• MDR Text Key: 197217880
• Report Number: 0001825034-2019-02470
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K101086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 51-104160
• Device Lot Number: 6028661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1